Betamethasone Dipropionate
- Product NDC
- 68071-4814
- 11-digit product format
- 680714814
- Labeler code
- 68071
- Product ID
- 68071-4814_1add9095-5135-157a-e063-6394a90ab926
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Dipropionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076592
- Marketing category
- ANDA
- Marketing start
- 2006-09-28
- Substance
- BETAMETHASONE DIPROPIONATE
- Active strength
- .5 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Betamethasone Dipropionate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 826Y60901U |
| Rxcui | 848176 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4814-5 | 2024-06-14 | C162847 | 48780-1 | ba0f9c33-1b2c-a910-e053-dadaa90a0b85 | 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 |
| 68071-4814-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1b2c-a910-e053-dadaa90a0b85 | 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 |
| 68071-4814-5 | 2021-02-17 | C162847 | 48780-1 | ba0f9c33-1b2c-a910-e053-dadaa90a0b85 | 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 |
| 68071-4814-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1b2c-a910-e053-dadaa90a0b85 | 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 |
|---|
| 68071-4814-5 | Betamethasone Dipropionate | 15 g in 1 TUBE | CREAM | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4814 | BETAMETHASONE DIPROPIONATE CREAM [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240616_84b37e6a-779e-5d43-e053-2a91aa0a16b7.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 |
|---|
| 68071-4814-5 | 68071481405 | 15 g in 1 TUBE (68071-4814-5) | 15 g | 2019-03-22 | 0000-00-00 | No | No | Current |