winlevi

Generic: clascoterone

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name winlevi
Generic Name clascoterone
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clascoterone 1 g/100g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-994
Product ID 47335-994_2abfc28a-6f85-d793-e063-6394a90a9490
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213433
Listing Expiration 2026-12-31
Marketing Start 2021-10-04

Pharmacologic Class

Established (EPC)
androgen receptor inhibitor [epc]
Mechanism of Action
androgen receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335994
Hyphenated Format 47335-994

Supplemental Identifiers

RxCUI
2474344 2474349
UPC
0347335994360
UNII
XN7MM8XG2M
NUI
N0000000243 N0000175560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name winlevi (source: ndc)
Generic Name clascoterone (source: ndc)
Application Number NDA213433 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE
  • 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE
source: ndc

Packages (2)

47335-994-36 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE 47335-994-94 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE

Ingredients (1)

clascoterone (1 g/100g)

Linked Drug Pages (1)

Winlevi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2abfc28a-6f85-d793-e063-6394a90a9490", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0347335994360"], "unii": ["XN7MM8XG2M"], "rxcui": ["2474344", "2474349"], "spl_set_id": ["1673a84b-7f5c-47ab-a99c-1e3db21a6a09"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (47335-994-36)  / 60 g in 1 TUBE", "package_ndc": "47335-994-36", "marketing_start_date": "20211004"}, {"sample": true, "description": "12 CARTON in 1 CASE (47335-994-94)  / 1 TUBE in 1 CARTON (47335-994-40)  / 2 g in 1 TUBE", "package_ndc": "47335-994-94", "marketing_start_date": "20211004"}], "brand_name": "Winlevi", "product_id": "47335-994_2abfc28a-6f85-d793-e063-6394a90a9490", "dosage_form": "CREAM", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "47335-994", "generic_name": "Clascoterone", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Winlevi", "active_ingredients": [{"name": "CLASCOTERONE", "strength": "1 g/100g"}], "application_number": "NDA213433", "marketing_category": "NDA", "marketing_start_date": "20211004", "listing_expiration_date": "20261231"}