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United States · US · US:64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b

KETOCONAZOLE

Orange BookUNIISPLATC D01AC08

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

Identification

ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeD01AC08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6438082706
    100 TABLET in 1 BOTTLE (64380-827-06)
  • ndc11
    6438082707
    500 TABLET in 1 BOTTLE (64380-827-07)

Annotations

UNII (FDA Substance ID)
R9400W927I
KETOCONAZOLE
RxCUI 6135
Orange Book
A210457
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": "64380-827_9781ff7c-39a7-4c61-a6ec-7f1947685c6b",
  "productndc": "64380-827",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210457",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Jun 18, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "KETOCONAZOLE",
  "proprietary_name": "KETOCONAZOLE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210457",
  "marketing_category": "ANDA",
  "nonproprietary_name": "KETOCONAZOLE",
  "start_marketing_date": "20180626",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code D01AC08.

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