Clobetasol Propionate
- Product NDC
- 51672-1293
- 11-digit product format
- 516721293
- Labeler code
- 51672
- Product ID
- 51672-1293_39092416-28c8-4d65-e063-6394a90a1e72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075224
- Marketing category
- ANDA
- Marketing start
- 1998-11-16
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- .5 mg/mL
- 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 |
|---|---|
| CLOBETASOL PROPIONATE | .5 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 779619577M |
| Rxcui | 861487 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 20abe2c3-3e80-d2b2-39eb-3156e4af4799 | Product name | 3 | 20250124 |
| 45ad92f8-d116-4c0c-851c-2e740b7d8e6f | Product name | 1 | 20250122 |
| 42be0ad5-6fd7-4f1b-8108-6d9dd7d571df | Product name | 7 | 20250107 |
| 3813b789-94b9-edd6-f010-6b926dd462e5 | Product name | 5 | 20230113 |
| 30eee8a1-850e-41ed-b5ab-761301aeab49 | Product name | 6 | 20221206 |
| 18e5b6f7-c414-b1f1-b684-17fdd02c215e | Product name | 4 | 20210927 |
| 1c87bbde-dd91-a122-db33-67ae814cb645 | Product name | 7 | 20210510 |
| 519b5875-7d7d-4aa6-9d3d-470fa1376595 | Product name | 4 | 20200227 |
| 98669154-3e9c-47da-8a2c-656ab71848be | Product name | 2 | 20180607 |
| 8d4f8539-436f-453b-8b76-5322d403fc8e | Product name | 1 | 20180131 |
| 837ac3c6-ee71-c5a6-6eba-c4065f37e9f5 | Product name | 2 | 20171010 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51672-1293-2 | Clobetasol Propionate | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 51672-1293-2 | Clobetasol Propionate | 25 mL in 1 BOTTLE, PLASTIC | SOLUTION | 25 | 6 | |
| 51672-1293-3 | Clobetasol Propionate | 50 mL in 1 BOTTLE, PLASTIC | SOLUTION | 50 | 6 | |
| 51672-1293-3 | Clobetasol Propionate | 1 in 1 CARTON | SOLUTION | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51672-1293-2 | ML - Milliliter | 51672-1293 | 7a53d619-ca59-4acd-b74b-8c135f1426d9 | 1 | 2013-02-13 |
| 51672-1293-3 | ML - Milliliter | 51672-1293 | a01e8fa5-0571-43ef-96cf-206e0b79501c | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| clobetasol propionate | ACTIVE INGREDIENT | 779619577M | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| clobetasol | ACTIVE MOIETY | ADN79D536H | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) | INACTIVE INGREDIENT | Z135WT9208 | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51672-1293 | CLOBETASOL PROPIONATE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241222_f5ea346b-f507-4224-88a6-4c891c4b1ad5.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861487 | clobetasol propionate 0.05 % Topical Solution | PSN | f5ea346b-f507-4224-88a6-4c891c4b1ad5 | 6 |
| 861487 | clobetasol propionate 0.5 MG/ML Topical Solution | SCD | f5ea346b-f507-4224-88a6-4c891c4b1ad5 | 6 |
| 861487 | clobetasol propionate 0.05 % Topical Solution | SY | f5ea346b-f507-4224-88a6-4c891c4b1ad5 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51672-1293-2 | 51672129302 | 1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-2) / 25 mL in 1 BOTTLE, PLASTIC | 1998-11-16 | 0000-00-00 | No | No | Current |
| 51672-1293-3 | 51672129303 | 1 BOTTLE, PLASTIC in 1 CARTON (51672-1293-3) / 50 mL in 1 BOTTLE, PLASTIC | 1998-11-16 | 0000-00-00 | No | No | Current |