NDC 0469-1425

Xospata

Gilteritinib

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.

• Product ID: 0469-1425_030d9de5-0d11-4205-a270-8519fbadb467
• NDC: 0469-1425
• Product Type: Human Prescription Drug
• Proprietary Name: Xospata
• Generic Name: Gilteritinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-29
• Marketing Category: NDA / NDA
• Application Number: NDA211349
• Labeler Name: Astellas Pharma US, Inc.
• Substance Name: GILTERITINIB FUMARATE
• Active Ingredient Strength: 40 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0469-1425-90

1 BOTTLE in 1 CARTON (0469-1425-90) > 90 TABLET in 1 BOTTLE

• Marketing Start Date: 2018-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0469-1425-90 [00469142590]

Xospata TABLET

• Marketing Category: NDA
• Application Number: NDA211349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-29

Drug Details

Active Ingredients

Ingredient	Strength
GILTERITINIB FUMARATE	40 mg/1

OpenFDA Data

• SPL SET ID: b5ff59aa-9c0d-49a8-9053-1f179b482383
• Manufacturer:
  • Astellas Pharma US, Inc.
• UNII:
  • 5RZZ0Z1GJT
• RxNorm Concept Unique ID - RxCUI:
  • 2105817
  • 2105811