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United States · US · US:35573-433_748e48d8-09d3-413c-b724-883b6b47f01e

KETOCONAZOLE

Orange BookUNIISPLATC D01AC08

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

Identification

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

Packs · 2

  • ndc11
    3557343302
    100 TABLET in 1 BOTTLE (35573-433-02)
  • ndc11
    3557343330
    30 TABLET in 1 BOTTLE (35573-433-30)

Annotations

UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A075912
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": "ORAL",
  "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": "35573-433_748e48d8-09d3-413c-b724-883b6b47f01e",
  "productndc": "35573-433",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075912",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jan 10, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "KETOCONAZOLE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075912",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketoconazole",
  "start_marketing_date": "20200410",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code D01AC08.

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