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United States · US · US:0591-3916_c2dcadb5-8ef3-4c6a-af4f-bf201184a6d0

Clindamycin phosphate and benzoyl peroxide

Orange BookUNIISPLATC D10AF

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeD10AF
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591391668
    1 BOTTLE, PUMP in 1 CARTON (0591-3916-68) / 50 g in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
A205128
AB
DailyMed SPL labels
1 version tracked
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",
  "spl_meta": {
    "27747e01-85eb-44de-a4a6-711a7799218a": {
      "match": "brand_token",
      "title": "CLINDAMYCIN PHOSPHATE SOLUTION [BRYANT RANCH PREPACK]",
      "spl_version": "111",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0591-3916_c2dcadb5-8ef3-4c6a-af4f-bf201184a6d0",
  "productndc": "0591-3916",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "205128",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5%;EQ 1.2% BASE",
        "product_no": "001",
        "approval_date": "Jun 19, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
  "proprietary_name": "Clindamycin phosphate and benzoyl peroxide",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA205128",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Clindamycin phosphate and benzoyl peroxide",
  "start_marketing_date": "20190219",
  "active_numerator_strength": "25; 10"
}

Related drugs

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