Ketoconazole

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeD01AC08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009075380
120 mL in 1 BOTTLE, PLASTIC (50090-7538-0)

Annotations

UNII (FDA Substance ID)

R9400W927I

KETOCONAZOLE

RxCUI 6135

Orange Book

A076942

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": "50090-7538_6e43133e-cf9e-454c-aeab-12fba2eff208",
  "productndc": "50090-7538",
  "dosage_form": "SHAMPOO, SUSPENSION",
  "orange_book": {
    "appl_no": "076942",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Apr 11, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "Ketoconazole",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA076942",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ketoconazole",
  "start_marketing_date": "20250207",
  "active_numerator_strength": "20"
}

Related drugs

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