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NDC 47335-0994-94 Winlevi 1 g/100g Details
Winlevi 1 g/100g
Winlevi is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is CLASCOTERONE.
Product Information
| NDC | 47335-0994 |
|---|---|
| Product ID | 47335-994_d78b5354-95c8-4bba-99a5-9cb339735547 |
| Associated GPIs | 90050011003720 |
| GCN Sequence Number | 081428 |
| GCN Sequence Number Description | clascoterone CREAM (G) 1 % TOPICAL |
| HIC3 | Q50 |
| HIC3 Description | TOPICAL ANTIANDROGENIC AGENTS |
| GCN | 48534 |
| HICL Sequence Number | 046803 |
| HICL Sequence Number Description | CLASCOTERONE |
| Brand/Generic | Brand |
| Proprietary Name | Winlevi |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Clascoterone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | CLASCOTERONE |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA213433 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 47335-0994-94 (47335099494)
| NDC Package Code | 47335-994-94 |
|---|---|
| Billing NDC | 47335099494 |
| Package | 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE |
| Marketing Start Date | 2021-10-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |