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United States · US · US:13548-132_110dde63-b7d7-49af-aa96-9daefccb84ff

Acanya

Orange BookUNIIATC D10AF

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeD10AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1354813250
    1 BOTTLE, PUMP in 1 CARTON (13548-132-50) / 50 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
N050819
ABAB
Raw payload (JSON)
{
  "unii": {
    "unii": "W9WZN9A0GM",
    "rxcui": "1418",
    "inchikey": "OMPJBNCRMGITSC-UHFFFAOYSA-N",
    "display_name": "BENZOYL PEROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "productid": "13548-132_110dde63-b7d7-49af-aa96-9daefccb84ff",
  "productndc": "13548-132",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "050819",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5%;EQ 1.2% BASE",
        "product_no": "001",
        "approval_date": "Oct 23, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3.75%;EQ 1.2% BASE",
        "product_no": "002",
        "approval_date": "Nov 24, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
  "proprietary_name": "Acanya",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "NDA050819",
  "marketing_category": "NDA",
  "nonproprietary_name": "Clindamycin Phosphate and Benzoyl Peroxide",
  "start_marketing_date": "20100726",
  "active_numerator_strength": "25; 10"
}

Related drugs

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