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NDC 42291-0901-28 Sunitinib Malate 12.5 mg/1 Details
Sunitinib Malate 12.5 mg/1
Sunitinib Malate is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is SUNITINIB MALATE.
MedlinePlus Drug Summary
Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus (tube that connects the throat with the stomach) in people with tumors that were not treated successfully with imatinib (Gleevec) or people who cannot take imatinib. Sunitinib is also used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys). Sunitinib is also used to help prevent the return of RCC in people who have RCC that has not spread and have had a kidney removed. Sunitinib is also used to treat pancreatic neuroendocrine tumors (pNET, a type of tumor that begins in certain cells of the pancreas) in people with tumors that have worsened and cannot be treated with surgery. Sunitinib 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 stop or slow the spread of cancer cells and may help shrink tumors.
Related Packages: 42291-0901-28Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Sunitinib
Product Information
| NDC | 42291-0901 |
|---|---|
| Product ID | 42291-901_0772f635-a03d-3c10-e063-6294a90a67ad |
| Associated GPIs | |
| GCN Sequence Number | 060326 |
| GCN Sequence Number Description | sunitinib malate CAPSULE 12.5 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 26452 |
| HICL Sequence Number | 033445 |
| HICL Sequence Number Description | SUNITINIB MALATE |
| Brand/Generic | Generic |
| Proprietary Name | Sunitinib Malate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sunitinib Malate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 12.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | SUNITINIB MALATE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213803 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0901-28 (42291090128)
| NDC Package Code | 42291-901-28 |
|---|---|
| Billing NDC | 42291090128 |
| Package | 28 CAPSULE in 1 BOTTLE (42291-901-28) |
| Marketing Start Date | 2023-10-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |