Itraconazole is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Ascend Laboratories, Llc. The primary component is Itraconazole.
| Product ID | 67877-454_36680831-25e4-4873-904d-fa237fc6fbb5 |
| NDC | 67877-454 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Itraconazole |
| Generic Name | Itraconazole |
| Dosage Form | Capsule, Coated Pellets |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-06-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208591 |
| Labeler Name | Ascend Laboratories, LLC |
| Substance Name | ITRACONAZOLE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2017-12-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208591 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-12 |
| Marketing Category | ANDA |
| Application Number | ANDA208591 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-06 |
| Marketing Category | ANDA |
| Application Number | ANDA208591 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-12-06 |
| Marketing Category | ANDA |
| Application Number | ANDA208591 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-06 |
| Marketing Category | ANDA |
| Application Number | ANDA208591 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-12-06 |
| Ingredient | Strength |
|---|---|
| ITRACONAZOLE | 100 mg/1 |
| SPL SET ID: | 349ffcf4-b2cd-4c93-9411-13c39275b8f3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-5100 | Itraconazole | itraconazole |
| 10147-0150 | itraconazole | itraconazole |
| 10147-1700 | itraconazole | ITRACONAZOLE |
| 13668-463 | Itraconazole | Itraconazole |
| 16714-743 | Itraconazole | Itraconazole |
| 16729-271 | Itraconazole | ITRACONAZOLE |
| 31722-006 | Itraconazole | Itraconazole |
| 42543-113 | Itraconazole | Itraconazole |
| 46708-204 | ITRACONAZOLE | itraconazole |
| 49884-239 | Itraconazole | Itraconazole |
| 50268-450 | Itraconazole | Itraconazole |
| 67877-454 | Itraconazole | Itraconazole |
| 68151-2718 | itraconazole | itraconazole |
| 68382-697 | itraconazole | itraconazole |
| 70771-1208 | itraconazole | itraconazole |
| 59746-282 | itraconazole | itraconazole |
| 60687-299 | Itraconazole | Itraconazole |
| 62332-204 | ITRACONAZOLE | ITRACONAZOLE |
| 65162-630 | Itraconazole | Itraconazole |
| 65162-087 | Itraconazole | Itraconazole |
| 63629-8168 | Itraconazole | Itraconazole |
| 70518-2872 | Itraconazole | Itraconazole |
| 0259-1420 | Onmel | ITRACONAZOLE |
| 50458-290 | SPORANOX | ITRACONAZOLE |
| 50458-295 | SPORANOX | itraconazole |
| 51862-462 | Tolsura | Itraconazole |