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United States · US · US:80861-115_3aaef113-7ec1-ba6b-e063-6394a90a67e9
Adapalene
Orange BookUNIISPLATC D10AD53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcne Free, LLC
CountryUS (United States)
ATC codeD10AD53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180861115011 g in 1 TUBE (80861-115-01)
Annotations
UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A091314
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": "80861-115_3aaef113-7ec1-ba6b-e063-6394a90a67e9",
"productndc": "80861-115",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "091314",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.1%",
"product_no": "001",
"approval_date": "Jul 1, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "ADAPALENE",
"proprietary_name": "Adapalene",
"active_ingred_unit": "g/g",
"application_number": "ANDA091314",
"marketing_category": "ANDA",
"nonproprietary_name": "Adaplane 0.1%",
"start_marketing_date": "20240105",
"active_numerator_strength": ".1"
}Related drugs
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