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United States · US · US:62332-662_6c1d4cda-e869-45e3-824f-21d3afd99f7e

ADAPALENE AND BENZOYL PEROXIDE

Orange BookUNIISPLATC D10AD

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD10AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6233266245
    1 BOTTLE, PUMP in 1 CARTON (62332-662-45) / 45 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A214185
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": "62332-662_6c1d4cda-e869-45e3-824f-21d3afd99f7e",
  "productndc": "62332-662",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "214185",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3%;2.5%",
        "product_no": "001",
        "approval_date": "Aug 4, 2022"
      }
    ],
    "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": "ANDA214185",
  "marketing_category": "ANDA",
  "nonproprietary_name": "adapalene and benzoyl peroxide topical",
  "start_marketing_date": "20220810",
  "active_numerator_strength": "3; 25"
}

Related drugs

Other records sharing ATC code D10AD.

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