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United States · US · US:76162-114_144e4db6-6253-4c98-b571-ea1108c177d6

Adapalene

Orange BookUNIISPLATC D10AD53

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

Identification

ManufacturerTopco Associates
CountryUS (United States)
ATC codeD10AD53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7616211405
    1 TUBE in 1 CARTON (76162-114-05) / 15 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A090962
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": "76162-114_144e4db6-6253-4c98-b571-ea1108c177d6",
  "productndc": "76162-114",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "090962",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Jun 2, 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": "ANDA090962",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Adapalene",
  "start_marketing_date": "20231130",
  "active_numerator_strength": "1"
}

Related drugs

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