Clotrimazole and Betamethasone Dipropionate
- Product NDC
- 68071-4134
- 11-digit product format
- 680714134
- Labeler code
- 68071
- Product ID
- 68071-4134_1a145449-0f8b-a78e-e063-6394a90ad576
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clotrimazole and Betamethasone Dipropionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA202894
- Marketing category
- ANDA
- Marketing start
- 2015-11-06
- Substance
- BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
- Active strength
- .5; 10 mg/g; mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS], 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
- Clotrimazole and Betamethasone Dipropionate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/g |
| CLOTRIMAZOLE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 826Y60901U, G07GZ97H65 |
| Rxcui | 308714 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4134-4 | 2024-06-04 | C162847 | 48780-1 | ba0f9c33-3b31-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use clotrimazole and betamethasone dipropionate cream safely and effectively. See full prescribing information for clotrimazole and betamethasone dipropionate cream. CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Cream USP, 1%/0.05% (base), for topical use Initial U.S. Approval: 1984 |
| 68071-4134-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-3b31-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use clotrimazole and betamethasone dipropionate cream safely and effectively. See full prescribing information for clotrimazole and betamethasone dipropionate cream. CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Cream USP, 1%/0.05% (base), for topical use Initial U.S. Approval: 1984 |
| 68071-4134-4 | 2021-03-01 | C162847 | 48780-1 | ba0f9c33-3b31-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use clotrimazole and betamethasone dipropionate cream safely and effectively. See full prescribing information for clotrimazole and betamethasone dipropionate cream. CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Cream USP, 1%/0.05% (base), for topical use Initial U.S. Approval: 1984 |
| 68071-4134-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3b31-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use clotrimazole and betamethasone dipropionate cream safely and effectively. See full prescribing information for clotrimazole and betamethasone dipropionate cream. CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Cream USP, 1%/0.05% (base), for topical use Initial U.S. Approval: 1984 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4134-4 | Clotrimazole and Betamethasone Dipropionate | 45 g in 1 BOX | CREAM | 45 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4134 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240606_5cc511e4-3e7d-70d6-e053-2a91aa0a8044.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 |
|---|
| 68071-4134-4 | 68071413404 | 45 g in 1 BOX (68071-4134-4) | 45 g | 2017-10-30 | 0000-00-00 | No | No | Current |