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NDC 68382-0245-78 imatinib mesylate 400 mg/1 Details
imatinib mesylate 400 mg/1
imatinib mesylate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is IMATINIB MESYLATE.
MedlinePlus Drug Summary
Imatinib is used to treat certain types of leukemia (cancer that begins in the white blood cells) and other cancers and disorders of the blood cells. Imatinib is also used to treat certain types of gastrointestinal stromal tumors (GIST; a type of tumor that grows in the walls of the digestive passages and may spread to other parts of the body). Imatinib is also used to treat dermatofibrosarcoma protuberans (a tumor that forms under the top layer of skin) when the tumor cannot be removed surgically, has spread to other parts of the body, or has come back after surgery. Imatinib 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 the spread of cancer cells.
Related Packages: 68382-0245-78Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Imatinib
Product Information
| NDC | 68382-0245 |
|---|---|
| Product ID | 68382-245_5ff42e82-696c-45bc-9cff-d0d3efe2cf4a |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | imatinib mesylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | imatinib mesylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/1 |
| Substance Name | IMATINIB MESYLATE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210658 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0245-78 (68382024578)
| NDC Package Code | 68382-245-78 |
|---|---|
| Billing NDC | 68382024578 |
| Package | 3 BLISTER PACK in 1 CARTON (68382-245-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-245-30) |
| Marketing Start Date | 2021-01-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |