xospata

Generic: gilteritinib

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xospata
Generic Name gilteritinib
Labeler astellas pharma us, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gilteritinib fumarate 40 mg/1

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-1425
Product ID 0469-1425_b1aef238-5cd9-47cb-a83f-1f5eac49f013
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211349
Listing Expiration 2026-12-31
Marketing Start 2018-11-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04691425
Hyphenated Format 0469-1425

Supplemental Identifiers

RxCUI
2105811 2105817
UNII
5RZZ0Z1GJT

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xospata (source: ndc)
Generic Name gilteritinib (source: ndc)
Application Number NDA211349 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (2)

0469-1425-21 1 BOTTLE in 1 CARTON (0469-1425-21) / 21 TABLET in 1 BOTTLE 0469-1425-90 1 BOTTLE in 1 CARTON (0469-1425-90) / 90 TABLET in 1 BOTTLE

Ingredients (1)

gilteritinib fumarate (40 mg/1)

Linked Drug Pages (1)

Xospata ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b1aef238-5cd9-47cb-a83f-1f5eac49f013", "openfda": {"unii": ["5RZZ0Z1GJT"], "rxcui": ["2105811", "2105817"], "spl_set_id": ["b5ff59aa-9c0d-49a8-9053-1f179b482383"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (0469-1425-21)  / 21 TABLET in 1 BOTTLE", "package_ndc": "0469-1425-21", "marketing_start_date": "20220430"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0469-1425-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "0469-1425-90", "marketing_start_date": "20181129"}], "brand_name": "Xospata", "product_id": "0469-1425_b1aef238-5cd9-47cb-a83f-1f5eac49f013", "dosage_form": "TABLET", "product_ndc": "0469-1425", "generic_name": "gilteritinib", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xospata", "active_ingredients": [{"name": "GILTERITINIB FUMARATE", "strength": "40 mg/1"}], "application_number": "NDA211349", "marketing_category": "NDA", "marketing_start_date": "20181129", "listing_expiration_date": "20261231"}