NDC 50090-1992

Ketoconazole

Ketoconazole

Ketoconazole is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Ketoconazole.

Product ID50090-1992_d132a315-0d44-4a41-b249-5fe5f160484e
NDC50090-1992
Product TypeHuman Prescription Drug
Proprietary NameKetoconazole
Generic NameKetoconazole
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1999-12-23
Marketing CategoryANDA / ANDA
Application NumberANDA075597
Labeler NameA-S Medication Solutions
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 Through2020-12-31

Packaging

NDC 50090-1992-1

7 TABLET in 1 BOTTLE (50090-1992-1)
Marketing Start Date2015-09-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-1992-1 [50090199201]

Ketoconazole TABLET
Marketing CategoryANDA
Application NumberANDA075597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-17

NDC 50090-1992-0 [50090199200]

Ketoconazole TABLET
Marketing CategoryANDA
Application NumberANDA075597
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-17
Marketing End Date2018-06-30

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE200 mg/1

OpenFDA Data

SPL SET ID:e63b2fa8-84db-4d42-8659-1905a29bbdb7
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]
    • Azole Antifungal [EPC]
    • Azoles [CS]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • Cytochrome P450 3A5 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]