NDC 68071-4012

Ketoconazole

Ketoconazole

Ketoconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals, Inc.. The primary component is Ketoconazole.

Product ID68071-4012_55140bff-58d3-3ae2-e054-00144ff88e88
NDC68071-4012
Product TypeHuman Prescription Drug
Proprietary NameKetoconazole
Generic NameKetoconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1999-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA075319
Labeler NameNuCare Pharmaceuticals, Inc.
Substance NameKETOCONAZOLE
Active Ingredient Strength200 mg/1
Pharm ClassesAzole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-4012-3

30 TABLET in 1 BOTTLE (68071-4012-3)
Marketing Start Date2017-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4012-3 [68071401203]

Ketoconazole TABLET
Marketing CategoryANDA
Application NumberANDA075319
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-24
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-05-22

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:55140bff-58d2-3ae2-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197853
  • Pharmacological Class

    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A5 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]