NDC product

Xospata

NDC 0469-1425 · Astellas Pharma US, Inc.

Key facts

Product NDC 0469-1425
Proprietary name Xospata
Nonproprietary name gilteritinib
Substances GILTERITINIB FUMARATE
Dosage form TABLET
Route ORAL
Labeler Astellas Pharma US, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA211349
Marketing start Nov 29, 2018
Listing certified through Dec 31, 2027

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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