NDC product

KOSELUGO

NDC 0310-0625 · AstraZeneca Pharmaceuticals LP

Key facts

Product NDC 0310-0625
Proprietary name KOSELUGO
Nonproprietary name SELUMETINIB
Substances SELUMETINIB
Dosage form CAPSULE
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA213756
Pharmacologic classes Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA]
Marketing start Apr 16, 2020
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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