Clobetasol Propionate
- Product NDC
- 51672-1350
- 11-digit product format
- 516721350
- Labeler code
- 51672
- Product ID
- 51672-1350_3961f9ed-9667-e4ae-e063-6394a90a279f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA200302
- Marketing category
- ANDA
- Marketing start
- 2012-07-02
- 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 table| Ingredient | Strength |
|---|
| CLOBETASOL PROPIONATE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 779619577M |
| Rxcui | 861505 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-1350-4 | Clobetasol Propionate | 1 in 1 CARTON | LOTION | 1 | | 8 |
| 51672-1350-4 | Clobetasol Propionate | 59 mL in 1 BOTTLE | LOTION | 59 | | 8 |
| 51672-1350-8 | Clobetasol Propionate | 1 in 1 CARTON | LOTION | 1 | | 8 |
| 51672-1350-8 | Clobetasol Propionate | 118 mL in 1 BOTTLE | LOTION | 118 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| clobetasol propionate | ACTIVE INGREDIENT | 779619577M | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Clobetasol | ACTIVE MOIETY | ADN79D536H | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked) | INACTIVE INGREDIENT | Z135WT9208 | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| mineral oil | INACTIVE INGREDIENT | T5L8T28FGP | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
| white wax | INACTIVE INGREDIENT | 7G1J5DA97F | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1350 | CLOBETASOL PROPIONATE LOTION [TARO PHARMACEUTICALS U.S.A., INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20241222_d4c73fb0-9675-4c41-a8bd-dd4cb2db1169.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 |
|---|
| 51672-1350-4 | 51672135004 | 1 BOTTLE in 1 CARTON (51672-1350-4) / 59 mL in 1 BOTTLE | 1 bottle | 2012-07-02 | 0000-00-00 | No | No | Current |
| 51672-1350-8 | 51672135008 | 1 BOTTLE in 1 CARTON (51672-1350-8) / 118 mL in 1 BOTTLE | 1 bottle | 2012-07-02 | 0000-00-00 | No | No | Current |