Clobetasol Propionate
- Product NDC
- 0168-0293
- 11-digit product format
- 001680293
- Labeler code
- 0168
- Product ID
- 0168-0293_42f6771f-30f7-467e-94da-2334ea31fdab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA075368
- Marketing category
- ANDA
- Marketing start
- 2000-02-15
- 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 | 861434, 861448, 861495 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0168-0293-15 | 2025-08-11 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-30 | 2025-08-11 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-60 | 2025-08-11 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-15 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-30 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-60 | 2025-07-29 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-15 | 2020-09-18 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-30 | 2020-09-18 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-60 | 2020-09-18 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-15 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
| 0168-0293-60 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-28f3-f274-e053-dbdaa90a6471 | CLOBETASOL PROPIONATE GEL, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE OINTMENT USP, 0.05% (Potency expressed as clobetasol propionate) |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0293-15 | Clobetasol Propionate | 15 g in 1 TUBE | GEL | 15 | | 13 |
| 0168-0293-30 | Clobetasol Propionate | 30 g in 1 TUBE | GEL | 30 | | 13 |
| 0168-0293-60 | Clobetasol Propionate | 60 g in 1 TUBE | GEL | 60 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0293 | CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 3 package rows | 20200919_2d4fa3a3-dc1c-4d3c-9959-4751e09d25be.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 |
|---|
| 0168-0293-15 | 00168029315 | 15 g in 1 TUBE (0168-0293-15) | 15 g | 2000-02-15 | 0000-00-00 | No | No | Current |
| 0168-0293-30 | 00168029330 | 30 g in 1 TUBE (0168-0293-30) | 30 g | 2000-02-15 | 0000-00-00 | No | No | Current |
| 0168-0293-60 | 00168029360 | 60 g in 1 TUBE (0168-0293-60) | 60 g | 2000-02-15 | 0000-00-00 | No | No | Current |