"0173-0912-61" National Drug Code (NDC)

Zejula 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)
(GlaxoSmithKline LLC)

NDC Code0173-0912-61
Package Description30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-61)
Product NDC0173-0912
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameZejula
Non-Proprietary NameNiraparib
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20230627
Marketing Category NameNDA
Application NumberNDA214876
ManufacturerGlaxoSmithKline LLC
Substance NameNIRAPARIB TOSYLATE MONOHYDRATE
Strength200
Strength Unitmg/1
Pharmacy ClassesPoly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]

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