Clobetasol Propionate
- Product NDC
- 42291-077
- 11-digit product format
- 422910077
- Labeler code
- 42291
- Product ID
- 42291-077_ff958b19-2ce4-442a-e053-6294a90a66a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- AvKARE
- Application
- ANDA209701
- Marketing category
- ANDA
- Marketing start
- 2020-06-18
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 779619577M |
| Rxcui | 861448 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-077-15 | Clobetasol Propionate | 15 g in 1 TUBE | OINTMENT | 15 | | 3 |
| 42291-077-15 | Clobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 42291-077-30 | Clobetasol Propionate | 30 g in 1 TUBE | OINTMENT | 30 | | 3 |
| 42291-077-30 | Clobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 42291-077-45 | Clobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 42291-077-45 | Clobetasol Propionate | 45 g in 1 TUBE | OINTMENT | 45 | | 3 |
| 42291-077-60 | Clobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | | 3 |
| 42291-077-60 | Clobetasol Propionate | 60 g in 1 TUBE | OINTMENT | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-077 | CLOBETASOL PROPIONATE OINTMENT [AVKARE] | 3 | Current NDC, Legacy NDC, 8 package rows | 20230707_a862de41-1500-9136-e053-2a95a90a6080.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 |
|---|
| 42291-077-15 | 42291007715 | 1 TUBE in 1 CARTON (42291-077-15) / 15 g in 1 TUBE | 1 tube | 2020-06-18 | 0000-00-00 | No | No | Current |
| 42291-077-30 | 42291007730 | 1 TUBE in 1 CARTON (42291-077-30) / 30 g in 1 TUBE | 1 tube | 2020-06-18 | 0000-00-00 | No | No | Current |
| 42291-077-45 | 42291007745 | 1 TUBE in 1 CARTON (42291-077-45) / 45 g in 1 TUBE | 1 tube | 2020-06-18 | 0000-00-00 | No | No | Current |
| 42291-077-60 | 42291007760 | 1 TUBE in 1 CARTON (42291-077-60) / 60 g in 1 TUBE | 1 tube | 2020-06-18 | 0000-00-00 | No | No | Current |