NDC product

ZEJULA

NDC 0173-0912 · GlaxoSmithKline LLC

Key facts

Product NDC 0173-0912
Proprietary name ZEJULA
Nonproprietary name niraparib
Substances NIRAPARIB TOSYLATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA214876
Pharmacologic classes Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]
Marketing start Jun 27, 2023
Listing certified through Dec 31, 2027

At a glance

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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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