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United States · US · US:68462-301_194a1ade-7163-4a56-ad50-6220398ede14
adapalene and benzoyl peroxide
Orange BookUNIISPLATC D10AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGlenmark Pharmaceuticals Inc., USA
CountryUS (United States)
ATC codeD10AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168462301471 BOTTLE, PUMP in 1 CARTON (68462-301-47) / 45 g in 1 BOTTLE, PUMP
- ndc11684623015545 g in 1 TUBE (68462-301-55)
Annotations
UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A208108
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": "68462-301_194a1ade-7163-4a56-ad50-6220398ede14",
"productndc": "68462-301",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "208108",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.1%;2.5%",
"product_no": "001",
"approval_date": "Nov 8, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ADAPALENE; BENZOYL PEROXIDE",
"proprietary_name": "adapalene and benzoyl peroxide",
"active_ingred_unit": "mg/g; mg/g",
"application_number": "ANDA208108",
"marketing_category": "ANDA",
"nonproprietary_name": "adapalene and benzoyl peroxide",
"start_marketing_date": "20191108",
"active_numerator_strength": "1; 25"
}Related drugs
Other records sharing ATC code D10AD.
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelPenlan Pharmaceuticals Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAltair Science Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelZydus Pharmaceuticals UK Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAristo Pharma Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAlliance Healthcare (Distribution) Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelZentiva Pharma UK Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelColorama Pharmaceuticals Ltd
- GBAdapalene 0.3% / Benzoyl peroxide 2.5% gelZentiva Pharma UK Ltd
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