| 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 | |||||||||||
| 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 0938-0921. | |||||||||||||||
| The time required to complete this information collection is estimated to average (40 hours) per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s) or suggestions 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 pending | |||||||||||||||
| Expiration Date ____________________. | |||||||||||||||
| File Type | application/vnd.ms-excel |
| Author | CMS |
| Last Modified By | CMS_DU |
| File Modified | 2008-11-21 |
| File Created | 2004-05-12 |