NDC 55505-196

Nizoral

Ketoconazole

Nizoral is a Topical Shampoo in the Human Otc Drug category. It is labeled and distributed by Kramer Laboratories. The primary component is Ketoconazole.

• Product ID: 55505-196_d962642c-0165-41c8-8b26-13e2e697fdfb
• NDC: 55505-196
• Product Type: Human Otc Drug
• Proprietary Name: Nizoral
• Generic Name: Ketoconazole
• Dosage Form: Shampoo
• Route of Administration: TOPICAL
• Marketing Start Date: 2022-06-16
• Marketing Category: NDA /
• Application Number: NDA020310
• Labeler Name: Kramer Laboratories
• Substance Name: KETOCONAZOLE
• Active Ingredient Strength: 10 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: 2023-12-31

Packaging

NDC 55505-196-33

1 BOTTLE in 1 CARTON (55505-196-33) > 125 mL in 1 BOTTLE

• Marketing Start Date: 2022-06-16
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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