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United States · US · US:49967-354_ad1c20be-a838-45e9-9667-40a06e3b6f6a
Adapalene
Orange BookUNIISPLATC D10AD53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerL�Oreal USA Products Inc
CountryUS (United States)
ATC codeD10AD53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1149967354011 TUBE in 1 CARTON (49967-354-01) / 45 g in 1 TUBE
- ndc1149967354021 TUBE in 1 CARTON (49967-354-02) / 15 g in 1 TUBE
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": "49967-354_ad1c20be-a838-45e9-9667-40a06e3b6f6a",
"productndc": "49967-354",
"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": "mg/g",
"application_number": "ANDA091314",
"marketing_category": "ANDA",
"nonproprietary_name": "Adapalene",
"start_marketing_date": "20190918",
"active_numerator_strength": "1"
}Related drugs
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