CLOBETASOL PROPIONATE
- Product NDC
- 64980-441
- 11-digit product format
- 649800441
- Labeler code
- 64980
- Product ID
- 64980-441_c8147912-7ee1-4348-8d78-2d2bfa17fefc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobetasol Propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA211401
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Marketing end
- 0000-00-00
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64980-441-03 | 2025-02-06 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-15 | 2025-02-06 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-45 | 2025-02-06 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-60 | 2025-02-06 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-03 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-15 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-45 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
| 64980-441-60 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5af8-d83d-e063-dadaa90ab31f | d09b6ca9-45d0-4a9e-b49d-9eac88504bea |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64980-441-03 | GM - Gram | 64980-441 | db147268-7da8-47a2-b51f-aaf0b6b36bff | 1 | 2019-05-02 |
| 64980-441-15 | GM - Gram | 64980-441 | 6ff4498a-1b4b-4525-b613-addd1d779111 | 1 | 2019-05-02 |
| 64980-441-45 | GM - Gram | 64980-441 | 95662a25-9460-483a-8b40-f28cf777d7f7 | 1 | 2019-05-02 |
| 64980-441-60 | GM - Gram | 64980-441 | f8fb08e0-fc18-4875-a6e1-3e9f0922d9a1 | 1 | 2019-05-02 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64980-441-03 | 64980044103 | 1 TUBE in 1 CARTON (64980-441-03) > 30 g in 1 TUBE | 1 tube | 2019-01-31 | 0000-00-00 | No | No | Current |
| 64980-441-15 | 64980044115 | 1 TUBE in 1 CARTON (64980-441-15) > 15 g in 1 TUBE | 1 tube | 2019-01-31 | 0000-00-00 | No | No | Current |
| 64980-441-45 | 64980044145 | 1 TUBE in 1 CARTON (64980-441-45) > 45 g in 1 TUBE | 1 tube | 2019-01-31 | 0000-00-00 | No | No | Current |
| 64980-441-60 | 64980044160 | 1 TUBE in 1 CARTON (64980-441-60) > 60 g in 1 TUBE | 1 tube | 2019-01-31 | 0000-00-00 | No | No | Current |