CMS-10110 ASP Addendum macro

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Overview

CMS 10110
Column Instructions

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Sheet 1: CMS 10110

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 is0938-0921. The time required to complete this information collection is estimated to average (13 hours) per response, including the time to review instructions, search existingdata resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) orsuggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850. CMS 10110 approval XX/XX/XXXX

* Should you be cutting and pasting data, please use the "Paste Special" function to avoid changing cell formatting.

Manufacturer's Name

NDC1

NDC2

NDC3

AlternateID

Generic Name

Brand Name

Strength of the Product

Volume Per Item

Number of Items Per NDC

Expiration Date of Final Lot Sold

Date of First Sale

FDA Application Number

FDA Application Supplement Number

FDA Approval Type

Additional FDA Application Number #1

Additional FDA Application Supplement Number #1

Additional FDA Application Number #2

Additional FDA Application Supplement Number #2

FDA Approval Date

ANDA

NDA

510K

BLA

PMA

Human Tissue

Vaccine

Other

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Sheet 2: Column Instructions

Column A - 1) This is a required free form field

Column B - 1) This is a requred field if Alternate ID is left blank 2) 5 digit number which identifies the labeler.

Column C - 1) This is a requred field if Alternate ID is left blank 2) 4 digit number which identifies the product.

Column D - 1) This is a requred field if Alternate ID is left blank 2) 2 digit number which identifies the package size.

Column E - 1) This is a required field if NDC1, NDC2, or NDC3 is left blank. 2) Numeric or alphanumeric alternate drug identifier (ex. An NHRIC number) can be entered. 3) Value must be 23 characters or less.

Column F - 1) This is a required field 2) Value must be any positive or negative numbers including zero 3) Value must include three decimal places. 4) ASP should not be greater than WAC but ASP could be greater than WAC 5) "$" is not an allowed value. Note: The CMS validation macro will flag an NDC if the ASP is greater than WAC .

Column G - 1) This is a required field 2) Must show three decimal places 3) Must be any valid positive or negative number including zero.

Column H - 1) This is a required field 2) WAC must be a valid or positive number including zero 3) Value must include three decimal places. 4) "$" is not an allowed value.

Column I - 1) This is a required free form field 2) Must be alphanumeric limited to 100 characters

Column J - 1) This is a required field free form field 2) Must be alphanumeric limited to 500 characters

Column K - 1) This is a required free form field 2) Limited to no more than 12 alphanumeric characters.

Column L - 1) This is a required field 2) Must be limited to a 10 digit numeric value.

Column M - 1) This is not a required field 2) Value must be in date format (MM/DD/YYYY).

Column N - 1) This is a required field 2) Value must be in date format (MM/DD/YYYY).

Column O - 1) This is not a required field 2) Data must be numeric and show three decimal places.

Column P - 1) This is a required field 2) Data may include a mixture of alpha numeric and numeric values 3) Value is limited to 6 or 7 characters 4) Character should not include dashes. 5) Field should not include blanks.

Column Q - 1) This is not a required field 2) Data may include a mixture of alpha numeric and numeric values 3) Value is limited to 4 numeric characters.

Column R - 1) This is not a required field 2) Data may include a mixture of alpha numeric and numeric values 3) Value is limited to 6 or 7 characters 4) Character should not include dashes.

Column S - 1) This is not a required field 2) Data may include a mixture of alpha numeric and numeric values 3) Value is limited to 4 characters.

Column T - 1) This is not a required field 2) Data may include a mixture of alpha numeric and numeric values 3) Value is limited to 6 or 7 characters 4) Character should not include dashes.

Column U - 1) This is not a required field 2) Data may include a mixture of alpha numeric and numeric values 3) Value is limited to 4 characters.

Column V - 1) This is a required field 2) Value must be in date format (MM/DD/YYYY) 3) if there is no approval date, baseline date should be set to 01/01/1965.

Column W - 1) This is a required field 2) Must only be values in FDA approval type list (ANDA, NDA, 510K, BLA, PMA, Human Tissue, Vaccine, Other).

Column X - 1) This is a required field if the FDA Approval Type is categorized as OTHER. This field should not be populated otherwise.

Column Y - 1) This is not a required field. Freeform field.