Ketoconazole

Orange BookUNIISPLATC D01AC08

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeD01AC08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807117093
30 g in 1 BOX (68071-1709-3)

Annotations

UNII (FDA Substance ID)

R9400W927I

KETOCONAZOLE

RxCUI 6135

Orange Book

A075638

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": "68071-1709_2a321ff6-d67f-0fca-e063-6394a90a8644",
  "productndc": "68071-1709",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "075638",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Dec 18, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "Ketoconazole",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA075638",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketoconazole",
  "start_marketing_date": "20021218",
  "active_numerator_strength": "20"
}

Related drugs

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