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United States · US · US:68462-486_03e34592-8f1e-49cd-8a20-824d2b18b4b5

clindamycin and benzoyl peroxide

Orange BookUNIISPLATC D10AF

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

Identification

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

Packs · 3

  • ndc11
    6846248619
    1 JAR in 1 CARTON (68462-486-19) / 25 g in 1 JAR
  • ndc11
    6846248624
    1 JAR in 1 CARTON (68462-486-24) / 35 g in 1 JAR
  • ndc11
    6846248627
    1 JAR in 1 CARTON (68462-486-27) / 50 g in 1 JAR

Annotations

UNII (FDA Substance ID)
W9WZN9A0GM
BENZOYL PEROXIDE
RxCUI 1418
Orange Book
A209252
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": "68462-486_03e34592-8f1e-49cd-8a20-824d2b18b4b5",
  "productndc": "68462-486",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "209252",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "5%;EQ 1% BASE",
        "product_no": "001",
        "approval_date": "Mar 14, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE",
  "proprietary_name": "clindamycin and benzoyl peroxide",
  "active_ingred_unit": "mg/g; mg/g",
  "application_number": "ANDA209252",
  "marketing_category": "ANDA",
  "nonproprietary_name": "clindamycin and benzoyl peroxide",
  "start_marketing_date": "20190314",
  "active_numerator_strength": "50; 10"
}

Related drugs

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