Back to search
🇺🇸

United States · US · US:71335-1849_e44810bf-246c-4043-bd20-28f512e0e347

KETOCONAZOLE

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeD01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133518491
    10 TABLET in 1 BOTTLE (71335-1849-1)
  • ndc11
    7133518492
    30 TABLET in 1 BOTTLE (71335-1849-2)
  • ndc11
    7133518493
    40 TABLET in 1 BOTTLE (71335-1849-3)
  • ndc11
    7133518494
    60 TABLET in 1 BOTTLE (71335-1849-4)
  • ndc11
    7133518495
    8 TABLET in 1 BOTTLE (71335-1849-5)
  • ndc11
    7133518496
    7 TABLET in 1 BOTTLE (71335-1849-6)
  • ndc11
    7133518497
    14 TABLET in 1 BOTTLE (71335-1849-7)
  • ndc11
    7133518498
    90 TABLET in 1 BOTTLE (71335-1849-8)

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": "71335-1849_e44810bf-246c-4043-bd20-28f512e0e347",
  "productndc": "71335-1849",
  "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.

Access this data programmatically

Query KETOCONAZOLE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.