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 |
Trademark Results [Nizoral]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIZORAL 97728117 not registered Live/Pending |
Kramer Consumer Healthcare, Inc. 2022-12-22 |
 NIZORAL 90726591 not registered Live/Pending |
Kramer Consumer Healthcare, Inc. 2021-05-21 |
 NIZORAL 73388680 1278609 Live/Registered |
Johnson & Johnson 1982-09-24 |
 NIZORAL 73257535 1170891 Dead/Cancelled |
Johnson & Johnson 1980-04-10 |
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