Search by Drug Name or NDC
NDC 00078-0526-51 Tasigna 200 mg/1 Details
Tasigna 200 mg/1
Tasigna is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is NILOTINIB.
MedlinePlus Drug Summary
Nilotinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) who have recently found to have this condition in adults and children 1 year of age and older. It is also used to treat certain types of CML in adults whose disease could not be treated successfully with imatinib (Gleevec) or adults who cannot take imatinib because of side effects. Nilotinib is also used to treat certain types of CML in children 1 year of age or older whose disease could not be treated successfully with other tyrosine kinase inhibitor therapies or who cannot take these medications because of side effects. Nilotinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.
Related Packages: 00078-0526-51Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nilotinib
Product Information
| NDC | 00078-0526 |
|---|---|
| Product ID | 0078-0526_b230c25f-3612-4e55-a69d-9cd1bdfd69b9 |
| Associated GPIs | 21531860200125 |
| GCN Sequence Number | 063319 |
| GCN Sequence Number Description | nilotinib HCl CAPSULE 200 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 99070 |
| HICL Sequence Number | 035149 |
| HICL Sequence Number Description | NILOTINIB HCL |
| Brand/Generic | Brand |
| Proprietary Name | Tasigna |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | nilotinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | NILOTINIB |
| Labeler Name | Novartis Pharmaceuticals Corporation |
| Pharmaceutical Class | Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 I |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022068 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00078-0526-51 (00078052651)
| NDC Package Code | 0078-0526-51 |
|---|---|
| Billing NDC | 00078052651 |
| Package | 28 CAPSULE in 1 BLISTER PACK (0078-0526-51) |
| Marketing Start Date | 2007-10-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |