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United States · US · US:70685-001_ba8ac2cf-fc6e-465e-84b9-518a041bfa5f

Ketoconazole

Orange BookUNIISPLATC D01AC08

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

Identification

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

Packs · 3

  • ndc11
    7068500101
    30 TABLET in 1 BOTTLE (70685-001-01)
  • ndc11
    7068500102
    100 TABLET in 1 BOTTLE (70685-001-02)
  • ndc11
    7068500103
    500 TABLET in 1 BOTTLE (70685-001-03)

Annotations

UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A219129
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": "70685-001_ba8ac2cf-fc6e-465e-84b9-518a041bfa5f",
  "productndc": "70685-001",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219129",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jul 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "Ketoconazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219129",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketoconazole",
  "start_marketing_date": "20250910",
  "active_numerator_strength": "200"
}

Related drugs

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