NDC 0078-0649
Gleevec
Imatinib Mesylate
Gleevec is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Imatinib Mesylate.
| Product ID | 0078-0649_1077cda3-a7c8-482d-b8c6-a87007bbfbac |
| NDC | 0078-0649 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gleevec |
| Generic Name | Imatinib Mesylate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-12-23 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021588 |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Substance Name | IMATINIB MESYLATE |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0078-0649-30
30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)
| Marketing Start Date | 2014-12-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0078-0649-30 [00078064930]
Gleevec TABLET
| Marketing Category | NDA |
| Application Number | NDA021588 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2014-12-23 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IMATINIB MESYLATE | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | 211ef2da-2868-4a77-8055-1cb2cd78e24b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Kinase Inhibitor [EPC]
- Protein Kinase Inhibitors [MoA]
NDC Crossover Matching brand name "Gleevec" or generic name "Imatinib Mesylate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0078-0401 | Gleevec | imatinib mesylate |
| 0078-0649 | Gleevec | imatinib mesylate |
| 66828-0030 | Gleevec | Gleevec |
| 0054-0248 | Imatinib Mesylate | Imatinib Mesylate |
| 0054-0249 | Imatinib Mesylate | Imatinib Mesylate |
| 0093-7629 | Imatinib Mesylate | Imatinib Mesylate |
| 0093-7630 | Imatinib Mesylate | Imatinib Mesylate |
| 0904-6621 | Imatinib Mesylate | Imatinib Mesylate |
| 0904-6901 | Imatinib Mesylate | Imatinib Mesylate |
| 16714-704 | imatinib mesylate | imatinib mesylate |
Trademark Results [Gleevec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GLEEVEC 78478393 3238831 Live/Registered |
Novartis AG 2004-09-03 |
 GLEEVEC 78056665 2675047 Live/Registered |
Novartis AG 2001-04-04 |
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