Imatinib Mesylate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Imatinib Mesylate.
| Product ID | 0378-2245_012fca57-d8e1-46dc-bfff-a3184f4de599 |
| NDC | 0378-2245 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Imatinib Mesylate |
| Generic Name | Imatinib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-09-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204644 |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Substance Name | IMATINIB MESYLATE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2017-09-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA204644 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-09-28 |
| Ingredient | Strength |
|---|---|
| IMATINIB MESYLATE | 100 mg/1 |
| SPL SET ID: | a1787fad-3612-43e1-98fa-ce62361e0b3c |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-0248 | Imatinib Mesylate | Imatinib Mesylate |
| 0054-0249 | Imatinib Mesylate | Imatinib Mesylate |
| 0093-7629 | Imatinib Mesylate | Imatinib Mesylate |
| 0093-7630 | Imatinib Mesylate | Imatinib Mesylate |
| 0378-2245 | Imatinib Mesylate | imatinib |
| 0378-2246 | Imatinib Mesylate | imatinib |
| 0904-6621 | Imatinib Mesylate | Imatinib Mesylate |
| 67877-634 | Imatinib mesylate | Imatinib mesylate |
| 67877-633 | Imatinib mesylate | Imatinib mesylate |
| 72485-202 | Imatinib mesylate | Imatinib mesylate |
| 0904-6901 | Imatinib Mesylate | Imatinib Mesylate |
| 16714-704 | imatinib mesylate | imatinib mesylate |
| 16714-705 | imatinib mesylate | imatinib mesylate |
| 42292-044 | Imatinib Mesylate | Imatinib Mesylate |
| 42292-043 | Imatinib Mesylate | Imatinib Mesylate |
| 47335-472 | imatinib mesylate | imatinib mesylate |
| 47335-475 | imatinib mesylate | imatinib mesylate |
| 50268-426 | Imatinib Mesylate | Imatinib Mesylate |
| 50268-427 | Imatinib Mesylate | Imatinib Mesylate |
| 51991-376 | IMATINIB MESYLATE | IMATINIB MESYLATE |
| 51991-377 | IMATINIB MESYLATE | IMATINIB MESYLATE |
| 60429-926 | Imatinib Mesylate | Imatinib Mesylate |
| 60505-2900 | Imatinib Mesylate | Imatinib Mesylate |
| 60429-925 | Imatinib Mesylate | Imatinib Mesylate |
| 60687-203 | Imatinib Mesylate | Imatinib Mesylate |
| 60505-2901 | Imatinib Mesylate | Imatinib Mesylate |
| 60687-192 | Imatinib Mesylate | Imatinib Mesylate |
| 64679-794 | Imatinib Mesylate | Imatinib Mesylate |
| 64679-793 | Imatinib Mesylate | Imatinib Mesylate |
| 65162-795 | Imatinib Mesylate | Imatinib Mesylate |
| 65162-794 | Imatinib Mesylate | Imatinib Mesylate |
| 68180-390 | IMATINIB MESYLATE | IMATINIB MESYLATE |
| 68180-391 | IMATINIB MESYLATE | IMATINIB MESYLATE |
| 51407-270 | Imatinib Mesylate | Imatinib Mesylate |
| 51407-269 | Imatinib Mesylate | Imatinib Mesylate |
| 72606-556 | Imatinib mesylate | Imatinib mesylate |
| 72606-557 | Imatinib mesylate | Imatinib mesylate |
| 0078-0401 | Gleevec | imatinib mesylate |
| 0078-0649 | Gleevec | imatinib mesylate |