Clobetasol Propionate (emollient)
- Product NDC
- 0168-0301
- 11-digit product format
- 001680301
- Labeler code
- 0168
- Product ID
- 0168-0301_60e61fbb-1d01-46ee-8a23-c1af3211f23a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA075430
- Marketing category
- ANDA
- Marketing start
- 1999-05-26
- 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 (emollient)
- 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 | 1992281 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0168-0301-15 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-27d0-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994 |
| 0168-0301-30 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-27d0-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994 |
| 0168-0301-60 | 2020-09-16 | C162847 | 48780-1 | ab0e2407-27d0-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994 |
| 0168-0301-15 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-27d0-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994 |
| 0168-0301-30 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-27d0-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994 |
| 0168-0301-60 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-27d0-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE CREAM, 0.05% (EMOLLIENT) CLOBETASOL PROPIONATE cream, 0.05% (EMOLLIENT), for topical use Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0301-15 | Clobetasol Propionate (emollient) | 1 in 1 CARTON | CREAM | 1 | | 10 |
| 0168-0301-15 | Clobetasol Propionate (emollient) | 15 g in 1 TUBE | CREAM | 15 | | 10 |
| 0168-0301-30 | Clobetasol Propionate (emollient) | 30 g in 1 TUBE | CREAM | 30 | | 10 |
| 0168-0301-30 | Clobetasol Propionate (emollient) | 1 in 1 CARTON | CREAM | 1 | | 10 |
| 0168-0301-60 | Clobetasol Propionate (emollient) | 60 g in 1 TUBE | CREAM | 60 | | 10 |
| 0168-0301-60 | Clobetasol Propionate (emollient) | 1 in 1 CARTON | CREAM | 1 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0301 | CLOBETASOL PROPIONATE (EMOLLIENT) (CLOBETASOL PROPIONATE) CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 6 package rows | 20220112_fdfd83ee-dfb4-4c12-a74e-a0053e34e08c.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 |
|---|
| 0168-0301-15 | 00168030115 | 1 TUBE in 1 CARTON (0168-0301-15) / 15 g in 1 TUBE | 1 tube | 1999-05-26 | 0000-00-00 | No | No | Current |
| 0168-0301-30 | 00168030130 | 1 TUBE in 1 CARTON (0168-0301-30) / 30 g in 1 TUBE | 1 tube | 1999-05-26 | 0000-00-00 | No | No | Current |
| 0168-0301-60 | 00168030160 | 1 TUBE in 1 CARTON (0168-0301-60) / 60 g in 1 TUBE | 1 tube | 1999-05-26 | 0000-00-00 | No | No | Current |