Ketodan

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerMedimetriks Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeD01AC08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4353853010
1 CAN in 1 CARTON (43538-530-10) / 100 g in 1 CAN

Annotations

UNII (FDA Substance ID)

R9400W927I

KETOCONAZOLE

RxCUI 6135

Orange Book

A091550

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": {
    "62f19bd8-926e-4e6b-9097-d81b894b95cc": {
      "match": "brand_token",
      "title": "KETODAN (KETOCONAZOLE) AEROSOL, FOAM [MEDIMETRIKS PHARMACEUTICALS, INC.]",
      "spl_version": "8",
      "published_date": "2024-12-09"
    }
  },
  "productid": "43538-530_354d4926-b665-4e7e-a86a-5baae165a470",
  "productndc": "43538-530",
  "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": "Ketodan",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA091550",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ketoconazole",
  "start_marketing_date": "20120615",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code D01AC08.

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