NDC 50090-3288

Ketoconazole

Ketoconazole

Ketoconazole is a Topical Shampoo, Suspension in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Ketoconazole.

Product ID50090-3288_b31453eb-266a-4283-986a-0de054ee71aa
NDC50090-3288
Product TypeHuman Prescription Drug
Proprietary NameKetoconazole
Generic NameKetoconazole
Dosage FormShampoo, Suspension
Route of AdministrationTOPICAL
Marketing Start Date2005-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA076942
Labeler NameA-S Medication Solutions
Substance NameKETOCONAZOLE
Active Ingredient Strength21 mg/mL
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 Through2022-12-31

Packaging

NDC 50090-3288-0

118.28 mL in 1 BOTTLE, PLASTIC (50090-3288-0)
Marketing Start Date2017-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-3288-0 [50090328800]

Ketoconazole SHAMPOO, SUSPENSION
Marketing CategoryANDA
Application NumberANDA076942
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-30
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20.5 mg/mL

OpenFDA Data

SPL SET ID:c29d4ddc-aa1c-41c6-99ce-9aff35d213f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 106336
  • Pharmacological Class

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