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United States · US · US:68308-662_9d93fe57-cd04-40ff-abe4-a18c27768f9c
adapalene and benzoyl peroxide
Orange BookUNIISPLATC D10AD
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma Inc.
CountryUS (United States)
ATC codeD10AD
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168308662451 BOTTLE, PUMP in 1 CARTON (68308-662-45) / 45 g in 1 BOTTLE, PUMP
Annotations
UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
N207917
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": "68308-662_9d93fe57-cd04-40ff-abe4-a18c27768f9c",
"productndc": "68308-662",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "207917",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.3%;2.5%",
"product_no": "001",
"approval_date": "Jul 15, 2015"
}
],
"appl_type": "N"
},
"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": "NDA207917",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "adapalene and benzoyl peroxide",
"start_marketing_date": "20220201",
"active_numerator_strength": "3; 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% gelZentiva Pharma UK Ltd
- GBAdapalene 0.1% / Benzoyl peroxide 2.5% gelAlliance Healthcare (Distribution) 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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