NDC 68071-1735

Ketoconazole

Ketoconazole

Ketoconazole is a Topical Shampoo, Suspension in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Ketoconazole.

Product ID68071-1735_7cd600c2-62bf-7120-e053-2a91aa0a2376
NDC68071-1735
Product TypeHuman Prescription Drug
Proprietary NameKetoconazole
Generic NameKetoconazole
Dosage FormShampoo, Suspension
Route of AdministrationTOPICAL
Marketing Start Date2016-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA076942
Labeler NameNuCare Pharmaceuticals,Inc.
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 Through2019-12-31

Packaging

NDC 68071-1735-4

120 mL in 1 BOTTLE (68071-1735-4)
Marketing Start Date2017-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-1735-4 [68071173504]

Ketoconazole SHAMPOO, SUSPENSION
Marketing CategoryANDA
Application NumberANDA076942
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-20

Drug Details

Active Ingredients

IngredientStrength
KETOCONAZOLE20.5 mg/mL

OpenFDA Data

SPL SET ID:54c69554-0b09-27e7-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 106336
  • UPC Code
  • 0368071173543
  • Pharmacological Class

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