NDC 50458-680

Nizoral

Ketoconazole

Nizoral is a Topical Shampoo in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Ketoconazole.

• Product ID: 50458-680_06febdbd-2183-4776-8243-754a5ca16211
• NDC: 50458-680
• Product Type: Human Prescription Drug
• Proprietary Name: Nizoral
• Generic Name: Ketoconazole
• Dosage Form: Shampoo
• Route of Administration: TOPICAL
• Marketing Start Date: 1990-08-31
• Marketing Category: NDA / NDA
• Application Number: NDA019927
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: KETOCONAZOLE
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50458-680-08

1 BOTTLE in 1 CARTON (50458-680-08) > 120 mL in 1 BOTTLE

• Marketing Start Date: 1990-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-680-08 [50458068008]

Nizoral SHAMPOO

• Marketing Category: NDA
• Application Number: NDA019927
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1990-08-31
• Marketing End Date: 2020-04-30

Drug Details

Active Ingredients

Ingredient	Strength
KETOCONAZOLE	20 mg/mL

OpenFDA Data

• SPL SET ID: efbc6388-90ce-11de-b92c-8b7156d89593
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • R9400W927I
• RxNorm Concept Unique ID - RxCUI:
  • 106336
  • 206978

Pharmacological Class

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

Medicade Reported Pricing

50458068008 NIZORAL 2% SHAMPOO

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Nizoral" or generic name "Ketoconazole"

NDC	Brand Name	Generic Name
50458-680	Nizoral	Nizoral
55505-191	Nizoral	Nizoral
55505-192	Nizoral	Nizoral
0378-8136	EXTINA	ketoconazole
40076-051	EXTINA	ketoconazole
0093-0900	Ketoconazole	Ketoconazole
0093-3219	Ketoconazole	Ketoconazole
0168-0099	ketoconazole	ketoconazole
0378-0261	Ketoconazole	ketoconazole
0713-0671	Ketoconazole	Ketoconazole
10147-0750	KETOCONAZOLE	ketoconazole
16714-955	Ketoconazole	Ketoconazole
21695-554	Ketoconazole	Ketoconazole
21695-555	Ketoconazole	Ketoconazole
21695-556	Ketoconazole	Ketoconazole
21695-562	Ketoconazole	Ketoconazole
33261-739	Ketoconazole	Ketoconazole
35573-433	KETOCONAZOLE	ketoconazole
43063-036	Ketoconazole	ketoconazole
43063-882	Ketoconazole	Ketoconazole
45802-465	Ketoconazole	Ketoconazole
45802-532	ketoconazole	ketoconazole
50090-0719	ketoconazole	ketoconazole
50090-0720	ketoconazole	ketoconazole
50090-1220	Ketoconazole	Ketoconazole
43538-530	Ketodan	ketoconazole
43538-531	Ketodan	ketoconazole
16110-080	Xolegel	ketoconazole