🇺🇸
United States · US · US:47335-994_2abfc28a-6f85-d793-e063-6394a90a9490
Winlevi
Orange BookUNIISPLATC D10AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD10AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1147335994361 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE
- ndc11473359949412 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
XN7MM8XG2M
CLASCOTERONE
RxCUI 2474340
Orange Book
N213433
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "XN7MM8XG2M",
"rxcui": "2474340",
"inchikey": "GPNHMOZDMYNCPO-PDUMRIMRSA-N",
"display_name": "CLASCOTERONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"1673a84b-7f5c-47ab-a99c-1e3db21a6a09": {
"match": "brand_token",
"title": "WINLEVI (CLASCOTERONE) CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "8",
"published_date": "2025-01-06"
}
},
"productid": "47335-994_2abfc28a-6f85-d793-e063-6394a90a9490",
"productndc": "47335-994",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "213433",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Aug 26, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLASCOTERONE",
"proprietary_name": "Winlevi",
"active_ingred_unit": "g/100g",
"application_number": "NDA213433",
"marketing_category": "NDA",
"nonproprietary_name": "Clascoterone",
"start_marketing_date": "20211004",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code D10AX06.
Access this data programmatically
Query Winlevi and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.