1% ketoconazole

UNIISPLATC D01AC08

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

Identification

ManufacturerTAGRID LLC

CountryUS (United States)

ATC codeD01AC08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8538400011
250 mL in 1 BOTTLE (85384-0001-1)

Annotations

UNII (FDA Substance ID)

R9400W927I

KETOCONAZOLE

RxCUI 6135

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": {
    "30b75584-3a1e-c125-e063-6294a90acaa7": {
      "match": "brand_token",
      "title": "1% KETOCONAZOLE (KETOCONAZOLE) SHAMPOO [TAGRID LLC]",
      "spl_version": "1",
      "published_date": "2025-03-31"
    }
  },
  "productid": "85384-0001_30b75584-3a1f-c125-e063-6294a90acaa7",
  "productndc": "85384-0001",
  "dosage_form": "SHAMPOO",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "1% ketoconazole",
  "active_ingred_unit": "mg/mL",
  "application_number": "M005",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "Ketoconazole",
  "start_marketing_date": "20250331",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code D01AC08.

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