Winlevi
- Product NDC
- 47335-994
- 11-digit product format
- 473350994
- Labeler code
- 47335
- Product ID
- 47335-994_2abfc28a-6f85-d793-e063-6394a90a9490
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clascoterone
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA213433
- Marketing category
- NDA
- Marketing start
- 2021-10-04
- Substance
- CLASCOTERONE
- Active strength
- 1 g/100g
- Pharmacologic classes
- Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Winlevi
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLASCOTERONE | 1 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | XN7MM8XG2M |
| Rxcui | 2474344, 2474349 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-994 | WINLEVI (CLASCOTERONE) CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 8 | Current NDC, Legacy NDC, 5 package rows | 20250104_1673a84b-7f5c-47ab-a99c-1e3db21a6a09.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 |
|---|
| 47335-994-36 | 47335099436 | 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE | 1 tube | 2021-10-04 | 0000-00-00 | No | No | Current |
| 47335-994-40 | 47335099440 | 2 g in 1 TUBE | 2 g | | | | | Historical |
| 47335-994-94 | 47335099494 | 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE | 12 carton | 2021-10-04 | 0000-00-00 | Yes | No | Current |