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NDC 00469-1425-21 Xospata 40 mg/1 Details
Xospata 40 mg/1
Xospata is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Astellas Pharma US, Inc.. The primary component is GILTERITINIB FUMARATE.
MedlinePlus Drug Summary
Gilteritinib is used to treat a certain type of acute myeloid leukemia (AML) that has worsened or returned after treatment with other chemotherapy medications. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.
Related Packages: 00469-1425-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Gilteritinib
Product Information
| NDC | 00469-1425 |
|---|---|
| Product ID | 0469-1425_92b78198-99b0-4895-aa24-ce776f9c5842 |
| Associated GPIs | 21533020200320 |
| GCN Sequence Number | 079318 |
| GCN Sequence Number Description | gilteritinib fumarate TABLET 40 MG ORAL |
| HIC3 | V1Q |
| HIC3 Description | ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS |
| GCN | 45803 |
| HICL Sequence Number | 045506 |
| HICL Sequence Number Description | GILTERITINIB FUMARATE |
| Brand/Generic | Brand |
| Proprietary Name | Xospata |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gilteritinib |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/1 |
| Substance Name | GILTERITINIB FUMARATE |
| Labeler Name | Astellas Pharma US, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211349 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00469-1425-21 (00469142521)
| NDC Package Code | 0469-1425-21 |
|---|---|
| Billing NDC | 00469142521 |
| Package | 1 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE |
| Marketing Start Date | 2022-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |