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United States · US · US:51672-1364_39099a6e-725a-aed2-e063-6294a90a39bc

ADAPALENE and BENZOYL PEROXIDE

Orange BookUNIISPLATC D10AD

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeD10AD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5167213643
    1 BOTTLE, PUMP in 1 CARTON (51672-1364-3) / 45 g in 1 BOTTLE, PUMP
  • ndc11
    5167213646
    1 TUBE in 1 CARTON (51672-1364-6) / 45 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
1L4806J2QF
ADAPALENE
RxCUI 60223
Orange Book
A206959
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": "51672-1364_39099a6e-725a-aed2-e063-6294a90a39bc",
  "productndc": "51672-1364",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "206959",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%;2.5%",
        "product_no": "001",
        "approval_date": "Jan 24, 2018"
      }
    ],
    "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": "ANDA206959",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ADAPALENE and BENZOYL PEROXIDE",
  "start_marketing_date": "20180124",
  "active_numerator_strength": "1; 25"
}

Related drugs

Other records sharing ATC code D10AD.

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