Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)

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Overview
Manufacturers have the option to use this template to upload product data into ASP.
You will enter the Product data for upload on the "Product Data Template" worksheet.
Data can be uploaded during the 30-day submission period after the end of the quarter.
It is recommended to upload this template no later than 5 days prior to the submission due date each quarter.
There is a separate template to upload financial data.
Requested Information
For each NDC or Alternate ID, enter the following:
column a. Manufacturer Name
column b. NDC1
column c. NDC2
column d. NDC3
column e. Alternate ID
column f. Alternate ID Website URL
column g. Brand Name
column h. Generic Name
column i. Volume Per Item
column j. Unit for Volume Per Item
column k. Number of Items Per NDC or Alternate ID
column l. Package Type
column m. Strength
column n. Unit for Strength
column o. FDA Application Number / Registration Number
column p. FDA Application Supplement Number
column q. Additional FDA Application Number #1
column r. Additional FDA Application Supplement Number #1
column s. Additional FDA Application Number #2
column t. Additional FDA Application Supplement Number #2
column u. FDA Approval Date
column v. FDA Approval Type
column w. First Marketing Date
column x. Date of First Sale for this Product
Do not change the column names.

Column Guidelines
Column Name

Format

Allowed/Sample Values

Required/optional

Manufacturer Name

alphanumeric

maximum of 250 characters

Required

NDC1

5-digit number

e.g. 12345

Required

NDC2

4-digit number

e.g. 1234

Required

NDC3

2-digit number

e.g. 12

Required

Alternate ID
Alternate ID Website URL
Brand Name
Generic Name
Volume Per Item
Unit for Volume per Item
Number of Items Per NDC or Alternate ID

alphanumeric

maximum of 23 characters
e.g. http://www.medicare.gov
maximum of 250 characters
maximum of 250 characters

Required

numeric

maximu of 9 digits and 2 decimal places

Required

Package Type
Strength
Unit for Strength

alphanumeric
numeric

2 characters
e.g. 300

Required
Required

FDA Application Number / Registration Number
FDA Application Supplement Number
Additional FDA Application Number #1
Additional FDA Application Supplement Number #1

alphanumeric
alphanumeric
alphanumeric
alphanumeric

maximum of 6 characters
maximum of 9 characters
maximum of 6 characters
maximum of 9 characters

Required
Optional
Optional
Optional

alphanumeric
alphanumeric
numeric

Optional
Required
Required

Additional FDA Application Number #2
Additional FDA Application Supplement Number #2
FDA Approval Date
FDA Approval Type

alphanumeric
alphanumeric
MM/DD/YYYY

maximum of 6 characters
maximum of 9 characters
e.g. 01/01/2023

Optional
Optional
Required
Required

First Marketing Date

MM/DD/YYYY

e.g. 01/01/2023

Required

Date of First Sale for this Product

MM/DD/YYYY

e.g. 01/01/2023

Required

Notes
When entering product data for the same Manufacturer more than once, be sure the spelling matches.
Special characters (comma, dash, period) allowed
First segment of the National Drug Code (NDC) that identifies the labeler. Products that do not have a NDC should only
use the Alternate ID column.
Not required if the product has an Alternate ID
Leading zero allowed
Not required if the product has an Alternate ID
The NDC2 is the sixth through the ninth digits of the 11-digit National Drug Code that identifies the product.
Not required if the product has an Alternate ID
The NDC3 is the last two digits of the 11-digit National Drug Code that identify the package size.
Not required if the product has an NDC.
Must match product ID exactly as listed publicly.
Special characters (colon, dash, period) allowed
Must have http:// or https:// prefix
Strength and package size should be entered in their respective fields unless it’s a part of the registered brand name
See valid values in Generic Name
See valid value in Unit of Volume per Item
For NDCs: Indicates the number units within the NDC package (ex: for a NDC that has 5 vials in a package, the number
of items per NDC is 5).
For Alternate IDs: Indicated the number of units within the Alternate ID. (ex: for an alternate ID that has 5 grafts in a
package, the number of items per Alternate ID is 5).
Enter SS, MS or NA (SD = Single dose, MD = Multi dose, NA = Not Applicable)
See valid values in Unit for Stength
Enter FDA Application Number for NDCs and Registration Number for Alternate IDs
Facility registration number for HCT/P products.

Must be prior to the current submission period start date
See valid values in FDA Approval Type
Must be after the FDA Approval Date
Must be prior to the current submission period start date
Date the NDC was first marketed after FDA approval.
Must be after the First Marketing Date
Must be prior to the current submission reporting period start date
Date the product was first sold.