ASPData revised _AddendumA revised 2009 with example data 112108

ASPData revised _AddendumA revised 2009 with example data 112108.xls

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

ASPData revised _AddendumA revised 2009 with example data 112108

OMB: 0938-0921

Document [xlsx]
Download: xlsx | pdf
Manufacturer's Name 11-Digit National Drug Code Manufacturer's
Average Sales Price
Number of ASP Units Wholesale
Acquisition Cost
Name of Drug or Biological Strength of the Product Volume
Per Item
Number of Items Per NDC Expiration Date
of Last Lot Sold
Date of First Sale Number of CAP Units Excluded FDA Application Number FDA Final Pre-Marketing Approval Date FDA Approval Type Descriptive Data Corrected
Currently collected data elements Proposed New Data Elements
EXAMPLE DATA














Centers for Medicare & Medicaid Services 01234567801 $10.94 2,097 $12.00 TRADE NAME 20 mg/ml 10 5 11/22/06 04/01/06 0 012345 01/20/06 NDA Insert "Y" to indicate that a data element other than Manufacturer's ASP or Number of ASP Units has changed.
Centers for Medicare & Medicaid Services 12345003510 $12.50 135 $13.50 BRAND NAME 50 mg tab 100 1

22.4 234560 prior to October 2003 BLA
Centers for Medicare & Medicaid Services 98765040101 $0.257 333,444
ACTIVE INGREDIENT 0.90% 3 5

0 654321 unknown ANDA
Centers for Medicare & Medicaid Services 98765123402 $123.45 99,000
TRADE NAME 100 mg* 1** 12

0.33 K056789 not currently available 510K






*powdered form **use "1" if powder form (or other specialized form such as a sheet) and Column G identifies amount of drug in one item



P123045 08/08/08 PMA
































































































































































































































































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Expiration Date ____________________.














File Typeapplication/vnd.ms-excel
AuthorCMS
Last Modified ByCMS_DU
File Modified2008-11-21
File Created2004-05-12

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