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United States · US · US:55910-880_64d9409f-7bb1-40b5-b961-f95abdb82c06

Adapalene

Orange BookUNIISPLATC D10AD53

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

Identification

ManufacturerDolgencorp, Inc. (DOLLAR GENERAL & REXALL)
CountryUS (United States)
ATC codeD10AD53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5591088005
    1 TUBE in 1 CARTON (55910-880-05) / 15 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A091314
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": "55910-880_64d9409f-7bb1-40b5-b961-f95abdb82c06",
  "productndc": "55910-880",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "091314",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Jul 1, 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": "ANDA091314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Adapalene",
  "start_marketing_date": "20191129",
  "active_numerator_strength": "1"
}

Related drugs

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