Ketoconazole is a Topical Shampoo, Suspension in the Human Prescription Drug category. It is labeled and distributed by Tolmar Inc.. The primary component is Ketoconazole.
Product ID | 63646-010_10974332-6e85-435a-96aa-862bddcdaa74 |
NDC | 63646-010 |
Product Type | Human Prescription Drug |
Proprietary Name | Ketoconazole |
Generic Name | Ketoconazole |
Dosage Form | Shampoo, Suspension |
Route of Administration | TOPICAL |
Marketing Start Date | 2016-10-01 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA076942 |
Labeler Name | TOLMAR Inc. |
Substance Name | KETOCONAZOLE |
Active Ingredient Strength | 21 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 | 2019-12-31 |
Marketing Start Date | 2005-04-11 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA076942 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2005-04-11 |
Ingredient | Strength |
---|---|
KETOCONAZOLE | 20.5 mg/mL |
SPL SET ID: | 7036d1f2-c3f9-41d4-bc72-dd70e1691128 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
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 |
21922-025 | Ketoconazole | Ketoconazole Cream, 2% |
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 |
68071-1614 | Ketoconazole | Ketoconazole |
68071-1743 | Ketoconazole | Ketoconazole |
68071-1735 | Ketoconazole | Ketoconazole |
68071-1709 | Ketoconazole | Ketoconazole |
68071-4012 | Ketoconazole | Ketoconazole |
68084-552 | Ketoconazole | Ketoconazole |
68151-2713 | Ketoconazole | Ketoconazole |
68258-3998 | Ketoconazole | Ketoconazole |
68788-9708 | Ketoconazole | Ketoconazole |
68788-9903 | Ketoconazole | Ketoconazole |
68788-9117 | Ketoconazole | Ketoconazole |
68788-9915 | Ketoconazole | Ketoconazole |
70518-0915 | Ketoconazole | Ketoconazole |
70518-1637 | ketoconazole | ketoconazole |
71205-105 | Ketoconazole | Ketoconazole |
71085-008 | Ketoconazole | Ketoconazole |
71335-0439 | Ketoconazole | Ketoconazole |
50090-1220 | Ketoconazole | Ketoconazole |
50090-1524 | Ketoconazole | Ketoconazole |
50090-3207 | Ketoconazole | Ketoconazole |
50090-1992 | Ketoconazole | Ketoconazole |
50090-1675 | Ketoconazole | Ketoconazole |
50090-3288 | Ketoconazole | Ketoconazole |
50090-3299 | Ketoconazole | Ketoconazole |
50436-4448 | ketoconazole | ketoconazole |
51672-4026 | Ketoconazole | Ketoconazole |
51672-1298 | Ketoconazole | Ketoconazole |
53217-015 | Ketoconazole | Ketoconazole |
53002-8150 | Ketoconazole | Ketoconazole |
53808-0842 | Ketoconazole | Ketoconazole |