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United States · US · US:49908-118_2b371635-a5d6-4596-e063-6394a90a8ee6
Adapalene
Orange BookUNIISPLATC D10AD53
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCALL INC. (dba Rochester Pharmaceuticals)
CountryUS (United States)
ATC codeD10AD53
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11499081181414 POUCH in 1 CARTON (49908-118-14) / 1.2 mL in 1 POUCH (49908-118-00)
Annotations
UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A204593
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": "49908-118_2b371635-a5d6-4596-e063-6394a90a8ee6",
"productndc": "49908-118",
"dosage_form": "SWAB",
"orange_book": {
"appl_no": "204593",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%",
"product_no": "001",
"approval_date": "Jan 5, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ADAPALENE",
"proprietary_name": "Adapalene",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA204593",
"marketing_category": "ANDA",
"nonproprietary_name": "Adapalene",
"start_marketing_date": "20190204",
"active_numerator_strength": "1"
}Related drugs
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