🇺🇸
United States · US · US:21922-051_2e5f2180-7624-4bb6-892d-e63491da2591
Adapalene Gel USP, 0.3%
Orange BookUNIISPLATC D10AD53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEncube Ethicals, Inc.
CountryUS (United States)
ATC codeD10AD53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1121922051061 TUBE in 1 CARTON (21922-051-06) / 45 g in 1 TUBE
- ndc1121922051501 BOTTLE, PUMP in 1 CARTON (21922-051-50) / 45 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A200298
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": "21922-051_2e5f2180-7624-4bb6-892d-e63491da2591",
"productndc": "21922-051",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "200298",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.3%",
"product_no": "001",
"approval_date": "Jun 14, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ADAPALENE",
"proprietary_name": "Adapalene Gel USP, 0.3%",
"active_ingred_unit": "mg/g",
"application_number": "ANDA200298",
"marketing_category": "ANDA",
"nonproprietary_name": "Adapalene Gel USP, 0.3%",
"start_marketing_date": "20230807",
"active_numerator_strength": "3"
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