KETOCONAZOLE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Burel Pharmaceuticals, Inc.. The primary component is Ketoconazole.
| Product ID | 35573-433_010f5ec1-e9e9-4eda-b4cf-9fb58d760c3c |
| NDC | 35573-433 |
| Product Type | Human Prescription Drug |
| Proprietary Name | KETOCONAZOLE |
| Generic Name | Ketoconazole |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-04-10 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075912 |
| Labeler Name | Burel Pharmaceuticals, Inc. |
| Substance Name | KETOCONAZOLE |
| Active Ingredient Strength | 200 mg/1 |
| 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 | 2021-12-31 |
| Marketing Start Date | 2020-04-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075912 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-04-10 |
| Marketing Category | ANDA |
| Application Number | ANDA075912 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-04-10 |
| Ingredient | Strength |
|---|---|
| KETOCONAZOLE | 200 mg/1 |
| SPL SET ID: | 57e81e13-b395-4dbd-b660-3038de41a838 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| 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 |