NDC 55505-191

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: 55505-191_681ce4eb-f27d-443d-a6b1-1debb812678c
• NDC: 55505-191
• Product Type: Human Otc Drug
• Proprietary Name: Nizoral
• Generic Name: Ketoconazole
• Dosage Form: Shampoo
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-01-07
• Marketing End Date: 2021-08-01
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020310
• Labeler Name: Kramer Laboratories
• Substance Name: KETOCONAZOLE
• Active Ingredient Strength: 10 mg/mL
• NDC Exclude Flag: N

Packaging

NDC 55505-191-33

125 mL in 1 BOTTLE (55505-191-33)

• Marketing Start Date: 2019-01-07
• Marketing End Date: 2021-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55505-191-33 [55505019133]

Nizoral SHAMPOO

• Marketing Category: NDA authorized generic
• Application Number: NDA020310
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-01-07

NDC 55505-191-40 [55505019140]

Nizoral SHAMPOO

• Marketing Category: NDA authorized generic
• Application Number: NDA020310
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-01-07

Drug Details

Active Ingredients

Ingredient	Strength
KETOCONAZOLE	10 mg/mL

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