DDR Product Data Specifications (CMS-367c)

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
The following data fields are required for the relevant collections:
DATA FIELDS – CMS-367a
Labeler Code: First segment of the National Drug Code (NDC) that identifies the labeler.
Numeric values; 5-digit field; right-justified; zero-padded.
Product Code: Second segment of the NDC. Alpha-numeric values; 4-digit field; rightjustified; zero-padded.
Package Size: Third segment of the NDC. Alpha-numeric values; 2-digit field; right-justified;
zero-padded.
Period Covered: Calendar quarter and year covered by the pricing data submission. Numeric
5-digit field; format: QYYYY.
Valid values for Q:
1 = January 1 - March 31
2 = April 1 - June 30
3 = July 1 - September 30
4 = October 1 - December 31
Valid values for YYYY: 4-digit calendar year equal to 1991 or later.
Average Manufacturer Price (AMP): The AMP per unit per product code for the period
covered, based on sales. If a drug is distributed in multiple package sizes, there will be one
“weighted” AMP for the product, which is the same for all package sizes. Compute to 7
decimal places, and round to 6 decimal places. Numeric values; 12-digit field: 5 whole numbers,
the decimal point (‘.’) and 6 decimal places; right-justified; zero-padded for AMP values with
fewer than 12 digits.
Best Price (BP): Per the statute and rebate agreement, the lowest price available per product
code, regardless of package size. Compute to 7 decimal places and round to 6 decimal places.
Zero or blank-filled for Non-Innovator Multiple Source drugs. Numeric values; 12-digit field: 5
whole numbers, the decimal point (‘.’) and 6 decimal places; right-justified; zero-padded for BP
values with fewer than 12 digits.

Form CMS-367a is used by manufacturers on a quarterly basis, to transmit pricing data for each of their covered outpatient drugs to
CMS either electronically or via file transfer. The use of Form CMS-367a on a quarterly basis by manufacturers is considered
mandatory under the authority of Section 1927 of the Social Security Act and the National Drug Rebate Agreement. Under the Privacy
Act of 1974 any personally identifying information obtained will be kept private to the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 34.8 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
Nominal Price (NP): Sales that meet the statutory/regulatory definition of NP. Labelers should
determine an aggregate dollar amount (by adding up all package sizes), and report this aggregate
NP dollar amount at the 9-digit NDC level. Total dollar figure, rounded to the nearest dollar.
Zero or blank-filled if an NDC has no NP sales for the quarter/year being reported, and for every
quarter/year in which an NDC is classified as a Non-Innovator Multiple Source drug. Numeric
values; 9-digit field; 9 whole numbers; right-justified; zero-padded for NP values with fewer
than 9 digits.
Customary Prompt Pay (CPP) Discount: Labelers should determine an aggregate dollar
amount (by adding up all package sizes), and report this aggregate CPP dollar amount at the 9digit NDC level. Total dollar figure, rounded to nearest dollar. Zero or blank-filled if the NDC
has no CPP discount for the quarter/year being reported. Numeric values; 9-digit field; 9 whole
numbers; right-justified; zero-padded for CPP Discount values with fewer than 9 digits.
Initial Drug Available for Line Extension: Identifies whether a line extension drug has an
Initial Drug available for the quarter/year being reported. 1-character field.
Valid Values:
Y = Yes
N = No
X = X - Not an LE Drug
Z = Not Applicable (for quarters prior to 2Q2016, or for quarters in which the NDC or labeler
was not active)
Initial Drug: Identifies the 9-digit NDC (from which a line extension drug is derived) with the
highest additional rebate ratio (calculated as a percentage of AMP) for the quarter/year being
reported. The Initial Drug’s additional rebate ratio is then used in the alternative URA
calculation for the line extension drug. The Initial Drug should fall under the same corporation
as the corresponding line extension drug, and must be active within the MDR Program at the
time it is reported as an Initial Drug. Zero-filled if the Initial Drug Available for LE field
contains a value of N, X, or Z. Numeric values; 9-digit field; right-justified; zero-padded.

Form CMS-367a is used by manufacturers on a quarterly basis, to transmit pricing data for each of their covered outpatient drugs to
CMS either electronically or via file transfer. The use of Form CMS-367a on a quarterly basis by manufacturers is considered
mandatory under the authority of Section 1927 of the Social Security Act and the National Drug Rebate Agreement. Under the Privacy
Act of 1974 any personally identifying information obtained will be kept private to the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 34.8 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
DATA FIELDS – CMS-367b
Labeler Code: First segment of the National Drug Code (NDC) that identifies the labeler.
Numeric values; 5-digit field; right-justified; zero-padded.
Product Code: Second segment of the NDC. Alpha-numeric values; 4-digit field; rightjustified; zero-padded.
Package Size: Third segment of the NDC. Alpha-numeric values; 2-digit field; right-justified;
zero-padded.
Month: Calendar month covered by the pricing data submission. Numeric values; 2-digit field;
format: MM.
Valid values for MM:
01 = January
02 = February
03 = March
04 = April
05 = May
06 = June
07 = July
08 = August
09 = September
10 = October
11 = November
12 = December
Year: Calendar year covered by the pricing data submission. Numeric values; 4-digit field;
format: YYYY.
Valid values for YYYY: 4-digit calendar year equal to 2007 or later.
Average Manufacturer Price (AMP): The AMP per unit per product code for the month/year
covered, based on sales. If a drug is distributed in multiple package sizes, there will be one
“weighted” AMP for the product, which is the same for all package sizes. Compute to 7
decimal places and round to 6 decimal places. Numeric values; 12-digit field: 5 whole numbers,
the decimal point (‘.’) and 6 decimal places; right-justified; zero-padded for AMP values with
fewer than 12 digits.

Form CMS-367b is used by manufacturers on a monthly basis, to transmit pricing data for each of their covered outpatient drugs to
CMS either electronically or via file transfer. The use of Form CMS-367b on a monthly basis by manufacturers is considered mandatory
under the authority of Section 1927 of the Social Security Act and the National Drug Rebate Agreement. Under the Privacy Act of 1974
any personally identifying information obtained will be kept private to the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 44.8 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
AMP Units: The total sum of all units included in the calculation of the AMP per product code
for the monthly reporting period. If a drug is distributed in multiple package sizes, there will be
one AMP unit value for the product, which is the same for all package sizes. Numeric values; 14digit field: 11 whole numbers, the decimal point (“.”) and 2 decimal places; right-justified; zeropadded.
5i Threshold: A value indicating whether the reported AMP was calculated using the alternate
5i AMP methodology (i.e., a 5i Threshold value of “Y”), or using the standard (non-5i)
methodology (i.e., a 5i Threshold value of “N”). A 5i Threshold value of “X” should be reported
if the NDC was not classified as a 5i drug for the month/year combination being reported. For
months prior to July 2014 (i.e., the month in which the 5i Threshold field was implemented), a 5i
Threshold value of “Z” should be reported to indicate the field was not applicable. 1-character
field.
Valid Values:
Y = Yes
N = No
X = Not a 5i drug
Z = Not Applicable

Form CMS-367b is used by manufacturers on a monthly basis, to transmit pricing data for each of their covered outpatient drugs to
CMS either electronically or via file transfer. The use of Form CMS-367b on a monthly basis by manufacturers is considered mandatory
under the authority of Section 1927 of the Social Security Act and the National Drug Rebate Agreement. Under the Privacy Act of 1974
any personally identifying information obtained will be kept private to the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 44.8 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
DATA FIELDS – CMS-367c
Labeler Code: First segment of the National Drug Code (NDC) that identifies the labeler.
Numeric values; 5-digit field; right-justified; zero-padded.
Product Code: Second segment of the NDC. Alpha-numeric values; 4-digit field; rightjustified; zero-padded.
Package Size: Third segment of the NDC. Alpha-numeric values; 2-digit field; right-justified;
zero-padded.
Drug Category: Indicates whether the drug is single source (S), innovator multiple source (I),
or non-innovator multiple source (N). 1 character field.
Valid values:
S = Single source
I = Innovator multiple source
N = Non-innovator multiple source
Unit Type: One of the 8 unit types by which a drug may be dispensed. 3-character field; leftjustified; blank-filled for Unit Type values with fewer than 3 characters.
Valid values:
AHF = Injectable Anti-Hemophilic Factor
CAP = Capsule
EA = EACH
GM = Gram
ML = Milliliter
SUP = Suppository
TAB = Tablet
TDP = Transdermal Patch
FDA Approval Date: NDA (including Authorized Generic), ANDA, or BLA approval date.
For covered outpatient drugs for which the FDA does not require approval, use 9/30/1990 or, if
the drug was first marketed after 9/30/1990, the actual date first marketed. Numeric values; 8digit field; format: MMDDYYYY.

Form CMS-367c is used by manufacturers to report a new drug to CMS either electronically or via file transfer, or when the
manufacturer has to report a change to the product data of an existing drug electronically or via file transfer. When needed, the use of
Form CMS-367c by manufacturers is considered mandatory under the authority of Section 1927 of the Social Security Act and the
National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to
the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 43.5 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c

Therapeutic Equivalence Code (TEC): FDA-assigned Therapeutic Equivalence Codes as
found in the FDA’s Orange Book: Approved Drug Products with Therapeutic Equivalence
Evaluations. Alpha-numeric values; 2 digit field.
Valid values:
AA = Products in Conventional Dosage Forms Not Presenting Bioequivalence Problems
AB = Products Meeting Necessary Bioequivalence Requirements assigned an FDA TEC of AB,
or AB1 through AB9
AN = Solutions and Powders for Aerosolization
AO = Injectable Oil Solutions
AP = Injectable Aqueous Solutions and, in Certain Instances, Intravenous Non-Aqueous
AT = Topical Products
BC = Extended-Release Dosage Forms (Capsules, Injectables, and Tablets)
BD = Active Ingredients and Dosage Form With Documented Bioequivalence Problems
BE = Delayed-Release Oral Dosage Forms
BN = Products in Aerosol-Nebulizer Drug Delivery Systems
BP = Active Ingredients and Dosage Forms with Potential Bioequivalence Problems
BR = Suppositories or Enemas That Deliver Drugs for Systemic Absorption
BS = Products Having Drug Standard Deficiencies
BT = Topical Products with Bioequivalence Issues
BX = Drug Products for Which the Data Are Insufficient To Determine Therapeutic Equivalence
NR = Not Rated
Market Date: For S, I and N drugs marketed under an FDA-approved application (e.g. ANDA,
BLA, NDA, NDA Authorized Generic), the earliest date the drug was first marketed under the
application number by any labeler For drugs marketed without an FDA-approved application
(e.g., OTC monograph, unapproved drug), the earliest date the drug was first marketed by any
labeler. For all drugs (i.e., those marketed with or without an FDA-approved application) that
were purchased or otherwise acquired from another labeler, the Market Date should be equal to
the Market Date of the original product. If a Market Date falls on a date that is earlier than
9/30/1990, CMS will change it to 9/30/1990 in both the Medicaid Drug Rebate (MDR) system
and the Drug Data Reporting for Medicaid (DDR) system since dates earlier than the start of the
Medicaid Drug Rebate Program have no bearing on the program. Numeric values; 8-digit field;
format: MMDDYYYY.
Termination Date: The date a drug is withdrawn from the market or the drug’s last lot
expiration date. Zero or blank-filled for drug without Termination Dates. Numeric values; 8digit field; format: MMDDYYYY.

Form CMS-367c is used by manufacturers to report a new drug to CMS either electronically or via file transfer, or when the
manufacturer has to report a change to the product data of an existing drug electronically or via file transfer. When needed, the use of
Form CMS-367c by manufacturers is considered mandatory under the authority of Section 1927 of the Social Security Act and the
National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to
the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 43.5 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
Drug Type: Identifies a drug as prescription (Rx) or over-the-counter (OTC).
Numeric values; 1-digit field.
Valid Values:
1 = Rx
2 = OTC
OBRA’90 Baseline AMP: The AMP per unit for the period that establishes the OBRA’90
Baseline AMP for single source or innovator multiple source drugs. There will be one weighted
Baseline AMP for the product, which applies to all package sizes. Compute to 7 decimal places
and round to 6 decimal places. Zero or blank-filled if the NDC does not have an OBRA ’90
Baseline AMP, and for all Non-Innovator Multiple Source drugs. Numeric values; 12-digit field:
5 whole numbers, the decimal point (‘.’) and 6 decimal places; right-justified; zero-padded for
OBRA ’90 Baseline AMP values with fewer than 12 digits.
Units Per Package Size (UPPS): The total number of units in the smallest dispensable amount
for the 11-digit NDC. Numeric values; 11-digit field: 7 whole numbers, the decimal point (‘.’)
and 3 decimal places; right-justified; zero-padded for UPPS values with fewer than 11 digits.
FDA Product Name: Drug name as it appears on FDA SPL listing. Alpha-numeric values; 63character field; left-justified; blank-filled for FDA Product Names fewer than 63 characters.
Package Size Intro Date (PSID): The date the package size is first available on the market.
Numeric values; 8-digit field; format: MMDDYYYY.
Purchased Product Date (PPD): The date the company currently holding legal title to the NDC
first markets the drug under this NDC (this date can result, for example, from the purchase of an
NDC from one company by another company, the re-designation of an NDC from one of a
company’s labeler codes to another of that same company’s labeler codes, cross-licensing
arrangements, etc.). Zero or blank-filled for drugs without Purchased Product Dates. Numeric
values; 8-digit field; format: MMDDYYYY.
5i Drug Indicator: Identifies whether a product is a 5i Drug. 1-character field.
Valid Values:
Y = Yes
N = No

Form CMS-367c is used by manufacturers to report a new drug to CMS either electronically or via file transfer, or when the
manufacturer has to report a change to the product data of an existing drug electronically or via file transfer. When needed, the use of
Form CMS-367c by manufacturers is considered mandatory under the authority of Section 1927 of the Social Security Act and the
National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to
the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 43.5 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
5i Route of Administration: Identifies the method by which the 5i drug is administered to a
patient. If a product is not a 5i drug, a value of “000” (Not Applicable) should be reported.
Numeric values; 3-digit field.
Valid Values:
000 =
001 =
002 =
003 =
004 =
005 =

Not Applicable
Implanted
Infused
Inhaled
Injected
Instilled

Covered Outpatient Drug (COD) Status: A category that identifies how a product meets the
statutory definition of a covered outpatient drug in accordance with sections 1927(k)(2) to
1927(k)(4) of the Social Security Act. Numeric values; 2-digit field.
Valid Values:
01 = Abbreviated New Drug Application (ANDA)
02 = Biological License Application (BLA)
03 = New Drug Application (NDA)
04 = NDA Authorized Generic
05 = DESI 5* – LTE/IRS drug for all indications
06 = DESI 6* – LTE/IRS drug withdrawn from market
07 = Prescription Pre-Natal Vitamin or Fluoride
08 = Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription
Pre-Natal Vitamin or Fluoride)
09 = OTC Monograph Tentative
10 = OTC Monograph Final
11 = Unapproved Drug – Drug Shortage
12 = Unapproved Drug – Per 1927(k)(2)(A)(ii)
13 = Unapproved Drug – Per 1927(k)(2)(A)(iii)
*NDCs with a COD Status of DESI 5/6 are not eligible for coverage or rebates under the
Medicaid Drug Rebate Program.

Form CMS-367c is used by manufacturers to report a new drug to CMS either electronically or via file transfer, or when the
manufacturer has to report a change to the product data of an existing drug electronically or via file transfer. When needed, the use of
Form CMS-367c by manufacturers is considered mandatory under the authority of Section 1927 of the Social Security Act and the
National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to
the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 43.5 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
FDA Application Number/OTC Monograph Number: For drugs with a COD status of
ANDA, BLA, NDA, or NDA Authorized Generic, this is the application number (assigned by
the FDA for approval to market a drug or biological in the United States) under which the NDC
is currently marketed. Numeric values; 7-digit field; padded with leading zeros as needed.
For drugs with a COD status of OTC Monograph Tentative or Final, this is the FDA’s regulatory
citation for the OTC. Alpha-numeric values; 7-digit field. For drugs with a COD Status of OTC
Monograph Final, the first four characters are a constant of “PART”; the last three characters are
the numeric values for the appropriate regulatory citation for the product (e.g., “225”). For drugs
with a COD Status of OTC Monograph Tentative, the first four characters are a constant of
“PART”; the last three characters are the numeric values for the appropriate regulatory citation
for the product, or three zeros if a Monograph Number is not available.
For drugs with a COD Status other than ANDA, BLA, NDA, NDA Authorized Generic, OTC
Monograph Final, or OTC Monograph Tentative, the FDA Application No./OTC Monograph
No. field should be zero-filled.
Line Extension Drug Indicator: Identifies whether a product is a line extension drug as
defined in Section 1927 (c)(2)(C) of the Social Security Act, including whether the drug is
excluded from the statutory definition of a line extension on the basis of being an abusedeterrent formulation (ADF). Labelers seeking an ADF exclusion at the time a drug is initially
reported in DDR should submit an initial value of “R” in this field for CMS review and
approval. 1-character field.
Valid Values:
Y = Yes
N = No (i.e., neither LE nor ADF)
R = Request for ADF Exclusion
E = Excluded (Due to ADF)*
*NOTE: This value may only be assigned by CMS and cannot be reported by a labeler.
Reactivation Date: The date on which a terminated product is re-introduced to the market.
(Note: This field may only be submitted online via DDR and is NOT part of the actual File
Format.)

Form CMS-367c is used by manufacturers to report a new drug to CMS either electronically or via file transfer, or when the
manufacturer has to report a change to the product data of an existing drug electronically or via file transfer. When needed, the use of
Form CMS-367c by manufacturers is considered mandatory under the authority of Section 1927 of the Social Security Act and the
National Drug Rebate Agreement. Under the Privacy Act of 1974 any personally identifying information obtained will be kept private to
the extent of the law.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-0578. The time required to complete
this information collection is estimated to average 43.5 hours per response, including the time to review instructions, gather the data
needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or
suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore,
Maryland 21244-1850.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
Labelers will have two data reporting options within DDR: first, they may key their data online on an NDC-by-NDC basis; second,
they may transfer a saved file to DDR. Labelers that key their data online will have an interactive “pop-up” help function when the
DDR has detected a potential data error. Labelers that opt to transfer their data via a file to DDR can check the system periodically for
a report that outlines any errors detected, as well as alerts for potential errors or data issues. These File Transfer Edit Reports include
the following error/ alert messages, along with instructions to the labeler to correct each data issue:
New Message
Product record contains a missing or
invalid labeler code
Pricing record contains a missing or
invalid labeler code
Missing or incorrect product code
Missing or incorrect package size
Deleted product - rejected by CMS
Drug Category is blank or is not S, I or N
Missing or invalid TEC
Missing Drug Type or drug type is not 1
or 2
OBRA ’90 Base AMP required

Type
Error

E10 Base AMP change is rejected
E11 Base AMP is less than 6 decimal places
and/or is not numeric
E12 Reserved
E13 Term Date is invalid and/or earlier than
the Market Date
E14 Missing or invalid Unit Type
E15 UPPS is less than 3 decimal places
and/or is not numeric and/or is missing or
invalid
E16 Future FDA Approval Date not allowed
E17 Missing or invalid Market Date
E18 Market Date not allowed
E19 Invalid FDA Approval Date

Error
Error

E1
E2
E3
E4
E5
E6
E7
E8
E9

Error
Error
Error
Error
Error
Error
Error
Error

Error
Error
Error
Error

Error
Error
Error
Error

Reason For Occurrence
Labeler code (NDC1) on the product record is blank or does not exist in
the database.
Labeler code (NDC1) on the price record is blank or does not exist in
the database.
Product code (NDC2) is blank or incorrect format or value.
Package size code (NDC3) is blank or incorrect format or value.
Product or package size has been deleted by CMS.
Drug Category field may not be blank and must be S, I or N.
TEC is blank or is invalid code.
Drug Type cannot be blank and must be 1 or 2.
Base AMP cannot be blank or contains zero when the drug category is S
or I and the market date is earlier than 10/01/1993.
Pricing changes after 12 quarters are not allowed.
Base AMP must be both numeric and 6 decimal places.
Reserved
Termination Date must be a valid date and later than the Market Date,
and should be zero or blank-filled if not present.
Unit Type is blank or not a valid value.
Units Per Package Size must be both numeric and 3 decimal places and
cannot be blank.
FDA Approval Date must be equal to current quarter or earlier.
Market Date cannot be blank and must be a valid date.
Market Date cannot be greater than current quarter plus one.
FDA Approval Date must be a valid date.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c

E20
E21
E22
E23
E24
E25
E26
E27
E28
E29
E30

E31
E32
E33
E34
E35
E36
E37
E38
E39
E40
E41
E42
E43

New Message
Market Date is less than FDA Approval
Date
Missing FDA Drug Name
Missing or invalid DESI
Product code does not exist
Missing year and/or quarter
Quarter must be 1, 2, 3, or 4
Invalid year
Year earlier than start of rebate program
Future quarterly pricing not allowed
Best Price must contain 6 decimal places
Best Price must be present, numeric and
greater than zero for category S or I
drugs
AMP must contain 6 decimal places
AMP must be present, numeric, and
greater than zero
Package size code does not exist
Pricing change rejected
AMP change not approved by CMS
Best Price change not approved by CMS
Monthly pricing data rejected
UPPS cannot contain decimals when
Unit Type is EA
Pricing data submitted for a period more
than 4 quarters after Termination Date
Missing month and/or year
Month must be a two-digit numeric value
Year earlier than start of monthly data
collection
Future monthly pricing not allowed

Type
Error

Reason For Occurrence
Market Date must be equal to or greater than the FDA Approval Date.

Error
Error
Error
Error
Error
Error
Error
Error
Error
Error

FDA Drug Name cannot be blank.
DESI cannot be blank and must equal 2, 3, 4, 5 or 6.
Product code (NDC2) not found - pricing rejected.
Quarter and/or year is blank (QYYYY).
Quarter is not equal to 1, 2, 3 or 4.
Year reported is not numeric or is greater than current year.
Year on the price record cannot be earlier than 1991.
Pricing quarter cannot be greater than current quarter.
Best Price is less than 6 decimal places.
Best Price is blank, non-numeric, or zero.

Error
Error

AMP is less than 6 decimal places.
AMP is blank, non-numeric, or zero.

Error
Error
Error
Error
Error
Error

Package size code (NDC3) not found - pricing rejected.
Pricing changes not allowed after 12 quarters.
Only Best Price change approved by CMS.
Only AMP change approved by CMS.
Monthly pricing changes not allowed after report period ends.
UPPS cannot contain decimals when Unit Type is EA.

Error
Error
Error
Error

Labeler submitted pricing data greater than 4 quarters after Termination
Date. Review for accuracy.
Month and/or year is blank (MMYYYY).
Month must be equal to 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, or 12.
Year on the price record cannot be earlier than 2007.

Error

Pricing month cannot be greater than current month.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
New Message
E44 Package size is terminated

Type
Error

E45 Monthly pricing data submitted for
monthly periods beyond Termination
Date
E46 Reserved
E47 Reserved
E48 Reserved
E49 Pricing change submitted after expiration
date
E50 Product code access denied
E51 Labeler code access denied
E52 Customary Prompt Pay Discount is
missing, not numeric, and/or is not equal
to a value of zero or greater
E53 Nominal Price is missing, not numeric
and/or is not equal to a value of zero or
greater
E54 Reserved
E55 Reserved
E56 DRA Base AMP submitted outside
allowable timeframe
E57 Multiple package size error – labeler
submitted different DRA Base AMPs
across multiple package sizes of the same
product
E58 Market Date change requires additional
pricing

Error

E59 Market Date change invalidates labeler
pricing

Error

Reason For Occurrence
Pricing record cannot be used to change AMP and/or Best Price because
package size was terminated for the quarter specified. Only active
package sizes can be used to change pricing.
Labeler submitted monthly pricing data greater than Termination Date.
Review for accuracy.

Error
Error
Error
Error

Reserved
Reserved
Reserved
Labeler submitted change after specified date.

Error
Error
Error

User does not have access to this product code.
User does not have access to this labeler code.
Customary Prompt Pay Discount must be present, numeric and equal to
a value of zero or greater.

Error

Nominal Price must be present, numeric and equal to a value of zero or
greater.

Error
Error
Error

Reserved
Reserved
The submission of DRA Base AMP is subject to requirements of CMS2238-FC.
DRA Base AMP was not weighted as required. Review/Correct.

Error

Error

Market Date change to earlier date results in additional pricing due from
labeler. If Market Date change is correct, labeler must process the
change online in DDR.
Market Date change to later date causes submitted pricing for earlier
quarters to become invalid. If Market Date change is correct, labeler
must process the change online in DDR.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
New Message
E60 Purchased Product Date field not
properly reported

Type
Error

E61 Purchased Product Date entry must be
performed manually online via DDR

Error

E62 Changing a Purchased Product Date to an Error
earlier date results in additional pricing
due from labeler
E63 Purchased Product Date is less than the
Market Date
E64 Purchased Product Date not allowed
E65 Package Size Intro Date not allowed
E66 Package Size Intro Date is less than
Market Date or Purchased Product Date
(if PPD present)
E67 Missing or Invalid Package Size Intro
Date
E68 Invalid Package Size Intro Date

Error

E69 Changing a Package Size Introduction
Date to an earlier date results in
additional pricing due from labeler

Error

E70 Package Size Introduction Date entry
must be performed manually online via
DDR

Error

Error
Error
Error

Reason For Occurrence
Purchased Product Date must be supplied. If Market Date is within
current reporting period, or if the product is being reported late and
there is no Purchased Product Date, then the Purchased Product Date
should be blank or zero-filled.
Purchased Product Date entered is later than the Market Date or
previously entered Purchased Product Date; therefore, prior period
pricing may exist. This action will cause the removal/deletion of
previously calculated URA values for the submitted pricing.
Change/entry of Purchased Product Date must be performed manually
in DDR.
Purchased Product Date entered is earlier than the previous Purchased
Product Date; therefore, additional pricing is due from the labeler. If
the new Purchased Product Date is correct, labeler must process the
change online in DDR.
Purchased Product Date must be equal to or greater than the Market
Date.
Purchased Product Date cannot be greater than current quarter plus one.
Package Size Intro Date cannot be greater than current quarter plus one.
Package Size Intro Date must be equal to or greater than the Market
Date or the Purchased Product Date (if PPD present).

Error

Package Size Intro Date cannot be blank and must be a valid date.

Error

At least one Package Size Introduction Date must be equal to Market
Date or Purchased Product Date.
Package Size Introduction Date entered is earlier than the previous
Package Size Introduction Date; therefore, additional pricing is due
from the labeler. If the new Package Size Introduction Date is correct,
labeler must process the change online in DDR.
Package Size Introduction Date entered is later than the previously
entered Package Size Introduction Date; therefore, prior period pricing
may exist. This action will cause the removal/deletion of previously
submitted AMP values. Change/entry of Package Size Introduction
Date must be performed manually in DDR.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
New Message
E71 Termination Date change invalidates
existing labeler data

Type
Error

E72 Multiple package size error – labeler
submitted different Market Dates across
multiple package sizes of the same
product
E73 Multiple package size error – labeler
submitted different FDA Approval Dates
across multiple package sizes of the same
product
E74 Multiple package size error – labeler
submitted different Purchased Product
Dates across multiple package sizes of
the same product
E75 Pricing quarter prior to Market Date
and/or Purchased Product Date

Error

E76 AMP Units must contain 2 decimal
places
E77 AMP Units must be present, numeric and
greater than or equal to zero
E78 Monthly pricing change rejected
E79 Multiple package sizes – AMP Units
problem
A1 Pricing submission equals current price
A2 Drug Category change not allowed

Reason For Occurrence
Termination Date change to an earlier date causes submitted pricing for
earlier months and/or quarters to become invalid. If Termination Date
is correct, labeler must process the change online in DDR.
Market Date was not the same across all package sizes for the same
product. Review/Correct.

Error

FDA Approval Date was not the same across all package sizes for the
same product. Review/Correct.

Error

Purchased Product Date was not the same across all package sizes for
the same product. Review/Correct.

Error

Error

Pricing quarter must be after the Market Date or Purchased Product
Date if one is present unless pricing quarter is being submitted to
establish the product’s OBRA ’93 Baseline AMP.
AMP Units value is less than 2 decimal places.

Error

AMP Units value is blank, non-numeric or less than zero.

Error
Error

Monthly pricing changes not allowed after 36 months.
AMP Units must be the same value across all package sizes.

Alert
Alert

Submitted pricing data equaled the pricing data already in the database.
Drug Category has a different value than the current value. Cannot
change from S/I to N or vice versa without CMS approval.
Unit Type change often requires changes to UPPS and price. Review
and adjust as needed
Database uses AMP submitted for Base AMP quarter. Base AMP not
required for N drugs.

A3 Warning: Unit Type changed

Alert

A4 Base AMP must be zero-filled if Market
Date is greater than 9/30/1993 or for N
drugs

Alert

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
New Message
A5 Market Date changes are not allowed

Type
Alert

A6 DESI change not allowed

Alert

A7 FDA Approval Date may not be after
Market Date
A8 Multiple package size OBRA ’90 Base
AMP problem

Alert
Alert

A9 Reserved
A10 Multiple package size AMP problem

Alert
Alert

A11 Multiple package size FDA Approval
Date problem
A12 Multiple package size Market Date
problem
A13 Drug Category change made
A14 Terminated package size - latest active
Best Price used
A15 Best Price greater than AMP

Alert

A16 Multiple package size – Best Price
problem

Alert

A17 DRA Base AMP must be zero-filled if
Market Date > 6/30/2007 or when drug
category is “N”
A18 Reserved
A19 DRA Base AMP must be a valid numeric
value with no blanks or special characters
A20 Terminated package size – latest active
AMP used
A21 Best Price not required for N drugs

Alert

Alert
Alert
Alert
Alert

Alert
Alert
Alert
Alert

Reason For Occurrence
Market Date cannot be changed after 12 quarters without prior CMS
approval.
DESI cannot be changed from a value of 2, 3, or 4 to a value of 5 or 6 or
vice-versa.
Previous FDA Approval Date remains in database.
OBRA ‘90 Base AMP was not weighted as required. CMS used highest
submitted Base AMP which will result in highest possible AMP.
Review/correct.
Reserved
AMP was not weighted as required. CMS used highest submitted AMP
which will result in highest possible AMP. Review/correct.
Initial FDA Approval Date does not change when new package size is
added.
Initial Market Date does not change when new package size is added.
Drug Category changed from S to I or vice-versa.
When all package sizes are terminated, the best price from the last
active quarter is used.
Best Price cannot be greater than AMP. CMS changed Best Price to
equal AMP. Review/correct
Best Price must be lowest price regardless of package size and the same
value across all package sizes. CMS used lowest submitted Best Price
which will result in highest possible URA. Review/correct.
DRA Base AMP is not required for NDCs with Market Dates >
6/30/2007 or for N drugs.
Reserved
DRA Base AMP, if supplied, must be numeric; 5 whole positive number
and 6 decimals or must be zero-filled.
When all package sizes are terminated, the AMP from the last active
quarter is used.
Best Price not required for N drugs.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
New Message
A22 Reserved
A23 Reserved
A24 Nominal Price invalid

Type
Alert
Alert
Alert

A25 Multiple Package Size – AMP not
submitted for all package sizes
A26 Product Record requires the submission
of a quarterly pricing record (QYYYY)
to establish the Baseline AMP
A27 Nominal Price submitted for N drug –
price will not appear in DDR
A28 Customary Prompt Pay Discount and/or
Nominal Price submitted for terminated
package size

Alert

A29 Valid Purchased Product Date value in
database
A30 Submitted Package Size Introduction
Date is earlier than current reporting
period

Alert

A31 Product Termination Date
removed/changed to a later date

Alert

A32 Reserved
A33 Monthly AMP Units increased/decreased
by 40% from last month.
A34 Reserved
A35 AMP Units not required prior to October
2010

Alert
Alert

Alert

Alert
Alert

Alert

Alert
Alert

Reason For Occurrence
Reserved
Reserved
For all active package sizes, Nominal Price must be a positive dollar
value or zero.
AMP value for all package sizes not submitted. AMP for submitted
package size will be stored for all active packages. Review/Correct.
A new S or I product record with a Market Date earlier than the current
quarter requires the submission of the quarterly AMP value needed to
establish the product’s OBRA ’93 Baseline AMP.
Nominal Price is not required for an N drug; therefore, the submitted
price will not appear in DDR.
When the last active package size of a product is terminated and it is
within four quarters after the Termination Date, the Customary Prompt
Pay Discount and/or Nominal Price field should be zero-filled for those
four quarters.
Purchased Product Date exists in the database. Removal of PPD can be
performed through the online system.
The Package Size Introduction Date submitted is earlier than the current
reporting period; therefore, prior period monthly AMP values were
automatically populated and prior quarterly NP and CPP values were
zero-filled. These populated values all require certification – please
review, correct where appropriate, and certify.
Removing or changing a product Termination Date to a later date results
in additional pricing due from labeler. Review, enter missing pricing
and certify any entered pricing.
Reserved
Monthly AMP Units increased/decreased by 40% from last month,
please review/correct.
Reserved
AMP Units are not required for periods prior to October 2010. Unit
information not kept.

Instructions to Labelers for CMS-367a, CMS-367b and CMS-367c
New Message
A36 AMP reported as 0.000001

Type
Alert

Reason For Occurrence
AMP reported as 0.000001. Verify this is the actual AMP value for the
NDC. If the AMP equals 0.000001 because the calculated AMP is
negative or zero, report the most recent prior AMP.