Betamethasone Dipropionate
- Product NDC
- 53002-8280
- 11-digit product format
- 530028280
- Labeler code
- 53002
- Product ID
- 53002-8280_bc8077f5-4fe5-42b9-98ad-8e39350ef86a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Dipropionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA076592
- Marketing category
- ANDA
- Marketing start
- 2006-09-28
- Marketing end
- 0000-00-00
- Substance
- BETAMETHASONE DIPROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-8280-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-64c9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983 |
| 53002-8280-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-64c9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983 |
| 53002-8280-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-64c9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983 |
| 53002-8280-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-64c9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983 |
| 53002-8280-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-64c9-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Betamethasone Dipropionate Cream USP (Augmented), 0.05% safely and effectively. See full prescribing information for Betamethasone Dipropionate Cream USP (Augmented), 0.05% . Betamethasone Dipropionate Cream USP (Augmented), 0.05% for topical use Initial U.S. Approval: 1983 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-8280-1 | Betamethasone Dipropionate | 15 g in 1 TUBE | CREAM | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-8280 | BETAMETHASONE DIPROPIONATE CREAM [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_13c20c58-3911-4d96-be09-7184ee1f7d4f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-8280-1 | 53002828001 | 15 g in 1 TUBE (53002-8280-1) | 15 g | 2018-10-01 | 0000-00-00 | No | No | Current |