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 ID55505-196_d962642c-0165-41c8-8b26-13e2e697fdfb
NDC55505-196
Product TypeHuman Otc Drug
Proprietary NameNizoral
Generic NameKetoconazole
Dosage FormShampoo
Route of AdministrationTOPICAL
Marketing Start Date2022-06-16
Marketing CategoryNDA /
Application NumberNDA020310
Labeler NameKramer Laboratories
Substance NameKETOCONAZOLE
Active Ingredient Strength10 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 Through2023-12-31

Packaging

NDC 55505-196-33

1 BOTTLE in 1 CARTON (55505-196-33) > 125 mL in 1 BOTTLE
Marketing Start Date2022-06-16
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
50458-680NizoralNizoral
55505-191NizoralNizoral
55505-192NizoralNizoral
0378-8136EXTINAketoconazole
40076-051EXTINAketoconazole
0093-0900KetoconazoleKetoconazole
0093-3219KetoconazoleKetoconazole
0168-0099ketoconazoleketoconazole
0378-0261Ketoconazoleketoconazole
0713-0671KetoconazoleKetoconazole
10147-0750KETOCONAZOLEketoconazole
16714-955KetoconazoleKetoconazole
21695-554KetoconazoleKetoconazole
21695-555KetoconazoleKetoconazole
21695-556KetoconazoleKetoconazole
21695-562KetoconazoleKetoconazole
33261-739KetoconazoleKetoconazole
35573-433KETOCONAZOLEketoconazole
43063-036Ketoconazoleketoconazole
43063-882KetoconazoleKetoconazole
45802-465KetoconazoleKetoconazole
45802-532ketoconazoleketoconazole
50090-0719ketoconazoleketoconazole
50090-0720ketoconazoleketoconazole
50090-1220KetoconazoleKetoconazole
50090-1524KetoconazoleKetoconazole
43538-530Ketodanketoconazole
43538-531Ketodanketoconazole
16110-080Xolegelketoconazole

Trademark Results [Nizoral]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NIZORAL
NIZORAL
90726591 not registered Live/Pending
Kramer Consumer Healthcare, Inc.
2021-05-21
NIZORAL
NIZORAL
73388680 1278609 Live/Registered
Johnson & Johnson
1982-09-24
NIZORAL
NIZORAL
73257535 1170891 Dead/Cancelled
Johnson & Johnson
1980-04-10

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