🇺🇸
United States · US · US:46708-549_2601af7f-4657-41f1-9b14-0efda19c971b
ADAPALENE
Orange BookUNIISPLATC D10AD53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeD10AD53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1146708549151 TUBE in 1 CARTON (46708-549-15) / 15 g in 1 TUBE
- ndc1146708549451 TUBE in 1 CARTON (46708-549-45) / 45 g in 1 TUBE
- ndc1146708549461 BOTTLE, PUMP in 1 CARTON (46708-549-46) / 45 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A213508
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1L4806J2QF",
"rxcui": "60223",
"inchikey": "LZCDAPDGXCYOEH-UHFFFAOYSA-N",
"display_name": "ADAPALENE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"07351ab9-ed46-4ef8-85f3-bb6cc7af17c3": {
"match": "brand_token",
"title": "ADAPALENE GEL [TOP CARE (TOPCO ASSOCIATES LLC)]",
"spl_version": "3",
"published_date": "2026-05-21"
}
},
"productid": "46708-549_2601af7f-4657-41f1-9b14-0efda19c971b",
"productndc": "46708-549",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "213508",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Jun 18, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ADAPALENE",
"proprietary_name": "ADAPALENE",
"active_ingred_unit": "mg/g",
"application_number": "ANDA213508",
"marketing_category": "ANDA",
"nonproprietary_name": "ADAPALENE",
"start_marketing_date": "20250326",
"active_numerator_strength": "3"
}Related drugs
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