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United States · US · US:45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9

ketoconazole

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeD01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4580253232
    1 CANISTER in 1 CARTON (45802-532-32) / 50 g in 1 CANISTER
  • ndc11
    4580253233
    1 CANISTER in 1 CARTON (45802-532-33) / 100 g in 1 CANISTER

Annotations

UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A091550
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": "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": "45802-532_f9768109-216c-49f3-be2a-d0c3eac142b9",
  "productndc": "45802-532",
  "dosage_form": "AEROSOL, FOAM",
  "orange_book": {
    "appl_no": "091550",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Aug 25, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "ketoconazole",
  "active_ingred_unit": "g/100g",
  "application_number": "ANDA091550",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketoconazole",
  "start_marketing_date": "20110830",
  "active_numerator_strength": "2"
}

Related drugs

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