NDC 68788-9117

Ketoconazole

Ketoconazole

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

Product ID68788-9117_7f77064a-3ee3-49dc-bf91-69010c7217b4
NDC68788-9117
Product TypeHuman Prescription Drug
Proprietary NameKetoconazole
Generic NameKetoconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA075273
Labeler NamePreferred 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 68788-9117-3

30 TABLET in 1 BOTTLE (68788-9117-3)
Marketing Start Date2011-05-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9117-3 [68788911703]

Ketoconazole TABLET
Marketing CategoryANDA
Application NumberANDA075273
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Inactivation Date2020-01-31

NDC 68788-9117-6 [68788911706]

Ketoconazole TABLET
Marketing CategoryANDA
Application NumberANDA075273
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Inactivation Date2020-01-31

NDC 68788-9117-1 [68788911701]

Ketoconazole TABLET
Marketing CategoryANDA
Application NumberANDA075273
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:be3eb758-2659-4f8b-abb7-cc57740e7331
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]