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NDC 00003-0528-11 SPRYCEL 50 mg/1 Details
SPRYCEL 50 mg/1
SPRYCEL is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E.R. Squibb & Sons, L.L.C.. The primary component is DASATINIB.
MedlinePlus Drug Summary
Dasatinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in people who can no longer benefit from other leukemia medications including imatinib (Gleevec) or in those who cannot take these medications because of side effects. Dasatinib is also used to treat a certain type of chronic CML in children. Dasatinib is also used to treat a certain type of acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in people who can no longer benefit from other leukemia medications or who cannot take these medications because of side effects. Dasatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
Related Packages: 00003-0528-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dasatinib
Product Information
| NDC | 00003-0528 |
|---|---|
| Product ID | 0003-0528_e69fc9e9-9b62-48ef-8c2d-7e07ba2fa5cf |
| Associated GPIs | 21531820000340 |
| GCN Sequence Number | 061100 |
| GCN Sequence Number Description | dasatinib TABLET 50 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 27258 |
| HICL Sequence Number | 033855 |
| HICL Sequence Number Description | DASATINIB |
| Brand/Generic | Brand |
| Proprietary Name | SPRYCEL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dasatinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | DASATINIB |
| Labeler Name | E.R. Squibb & Sons, L.L.C. |
| Pharmaceutical Class | Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021986 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00003-0528-11 (00003052811)
| NDC Package Code | 0003-0528-11 |
|---|---|
| Billing NDC | 00003052811 |
| Package | 1 BOTTLE in 1 CARTON (0003-0528-11) / 60 TABLET in 1 BOTTLE |
| Marketing Start Date | 2006-06-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |