7 Manufacturer Data Fields for 340B Ceiling Price

Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations

Manufacturer Data Fields for 340B Ceiling Price

OMB: 0915-0327

Document [pdf]
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Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327

Health Resources and Services Administration (HRSA)
340B Quarterly Pricing Data
Text File for Transfer to HRSA
Source: Drug Manufacturers
Target: HRSA
Field

Size

Position

Remarks

Labeler Code

5

1-5

NDC #1

Product Code

4

6-9

NDC #2

Package Size Code

2

10-11

NDC3

Period Covered

5

12-16

QYYYY (Qtr/Yr)

Average Manufacturer Price
(AMP)

12

17-28

99999.999999

Unit Rebate Amount (URA)

12

29-40

99999.999999

Package Size

11

41-51

9999999.999

Unit Type

3

52-54

(e.g., CAP, TAB, ML)

Case Pack

11

55-65

9999999.999

340B Price

12

66-77

999999999.99

FDA Product Name

65

78-142

FDA Product Name

Labeler Name

39

143-181

Name of Manufacturer/Labeler

Wholesale Acquisition Cost
WAC

12

182-193

999999999.99

Notes: Open field text of up to 1000 characters
Data Field Definitions:
Labeler Code: First segment of National Drug Code that identifies the labeler. Numeric values
only, 5-digit field, right-justified and zero-filled for 4-digit labeler codes.
Product Code: Second segment of National Drug Code. Alpha-numeric values, 4-digit field,
right-justified, zero-filled for 3-digit product codes.
Package Size Code: Third segment of National Drug Code. Alpha-numeric values, 2-digit field,
right-justified, zero-filled for 1-digit package size codes.
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Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327

Period Covered: Calendar quarter and year covered by data submission. Numeric 5-digit field,
QYYYY.
Average Manufacturer Price: Average manufacturer price (AMP) per unit per product code
only 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 will be the same for all package sizes.
Numeric values, 12-digit field; 5 whole numbers, the decimal and 6 decimal places; rightjustified; zero-filled. Compute to 7 decimal places and round to 6 decimal places.
Unit Rebate Amount (URA): -The average total rebate required under section 1927(c) of the
Social Security Act with respect to the drug (for a unit of the dosage form and strength involved)
during the quarterly reporting period. Refer to Centers for Medicare & Medicaid Services
(CMS) Medicaid Drug Rebate Program website for URA calculation data. Numeric values, 12digit field; 5 whole numbers, the decimal and 6 decimal places; right-justified; zero-filled
Compute to 6 decimal places and round to 4 decimal places, pad positions 5 and 6 with zeros.
Package Size: The number of billing units in the labeled quantity from which the pharmacist
dispenses.
Unit Type: One of the eight unit types by which the drug can be dispensed.
Valid Values:
AHF
=
CAP
=
SUP
=
GM
=
ML
=
TAB
=
TDP
=
EA
=

refers only to injectable Anti-Hemophilic Factor units
Capsule
Suppository
Gram
Milliliter
Tablet
Transdermal patch
EACH (Refers to drugs not identifiable by any other unit type)

Case Pack: the number of salable units in the shipping container.
340B Price: 340B Price = (AMP-URA)*PS*CSP for the quarterly reporting period. Numeric
values, 12-digit field; 9 whole numbers, the decimal, and 2 decimal places; right-justified; zero
filled. Round to 2 decimal places.
FDA Product Name: Drug name as approved by the FDA.
Labeler Name: Corporate name of entity identified by the labeler code.
Wholesale Acquisition Cost (WAC): Published catalog or list price for a drug product to
wholesalers. Numeric values, 12-digit field; 9 whole numbers, the decimal, and 2 decimal places;
right-justified; zero filled. Round to 2 decimal places.
Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number for this project is 0915-0327. Public
reporting burden for this collection of information is estimated to average .5 hours per response, including the time for reviewing
instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding

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Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau
OMB No. 0915-0327
this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA
Reports Clearance Officer, 5600 Fishers Lane, Room 14N-39, Rockville, Maryland, 20857.

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File Typeapplication/pdf
File TitleManufacturer Data Fields for 340B Ceiling Price-FINAL VERSION
AuthorLeah Baskin
File Modified2022-10-31
File Created2022-10-31

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