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United States · US · US:70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69

Ketoconazole

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerXiromed, LLC
CountryUS (United States)
ATC codeD01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7070016019
    50 g in 1 CAN (70700-160-19)
  • ndc11
    7070016020
    100 g in 1 CAN (70700-160-20)

Annotations

UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A213601
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "R9400W927I",
    "rxcui": "6135",
    "inchikey": "XMAYWYJOQHXEEK-ZEQKJWHPSA-N;XMAYWYJOQHXEEK-OZXSUGGESA-N",
    "display_name": "KETOCONAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "abc2446c-cdc2-48fe-80f2-cf0038d2a85e": {
      "match": "brand_token",
      "title": "KETOCONAZOLE (KETOCONAZOLE CREAM, 2%) CREAM [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "4",
      "published_date": "2026-05-20"
    }
  },
  "productid": "70700-160_1d2842b4-06d6-8054-d485-cb30f0ed4f69",
  "productndc": "70700-160",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "213601",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "May 21, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "Ketoconazole",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA213601",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketoconazole Foam",
  "start_marketing_date": "20210521",
  "active_numerator_strength": "20"
}

Related drugs

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