Clobetasol Propionate Cream 0.05%
- Product NDC
- 68788-4001
- 11-digit product format
- 687884001
- Labeler code
- 68788
- Product ID
- 68788-4001_1917a2a1-1591-4383-8466-ae12988b209f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobetasol Propionate Cream 0.05%
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA212982
- Marketing category
- ANDA
- Marketing start
- 2025-08-01
- Substance
- CLOBETASOL PROPIONATE
- 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
- Clobetasol Propionate Cream 0.05%
- Brand name suffix
- Clobetasol Propionate Cream 0.05%
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 779619577M |
| Rxcui | 861495 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 779619577M | CLOBETASOL PROPIONATE | 25122-46-7 | CLOBETASOL PROPIONATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4001-6 | 68788400106 | 60 g in 1 TUBE (68788-4001-6) | 60 g | 2025-08-01 | No | No | Historical |