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United States · US · US:72162-2295_e725e42a-8a28-438f-8476-ce1e54ac33dc

Adapalene Gel USP, 0.3%

Orange BookUNIISPLATC D10AD53

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD10AD53
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7216222952
    1 TUBE in 1 CARTON (72162-2295-2) / 45 g in 1 TUBE
  • ndc11
    7216222954
    1 BOTTLE, PUMP in 1 CARTON (72162-2295-4) / 45 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A200298
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": "72162-2295_e725e42a-8a28-438f-8476-ce1e54ac33dc",
  "productndc": "72162-2295",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "200298",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Jun 14, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ADAPALENE",
  "proprietary_name": "Adapalene Gel USP, 0.3%",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA200298",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Adapalene Gel USP, 0.3%",
  "start_marketing_date": "20230505",
  "active_numerator_strength": "3"
}

Related drugs

Other records sharing ATC code D10AD53.

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