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"65757-653-40" National Drug Code (NDC)

Lybalvi 1 BOTTLE in 1 CARTON (65757-653-40) / 7 TABLET, FILM COATED in 1 BOTTLE
(Alkermes, Inc.)

NDC Code65757-653-40
Package Description1 BOTTLE in 1 CARTON (65757-653-40) / 7 TABLET, FILM COATED in 1 BOTTLE
Product NDC65757-653
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLybalvi
Non-Proprietary NameOlanzapine And Samidorphan L-malate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20210920
Marketing Category NameNDA
Application NumberNDA213378
ManufacturerAlkermes, Inc.
Substance NameOLANZAPINE; SAMIDORPHAN L-MALATE
Strength15; 10
Strength Unitmg/1; mg/1
Pharmacy ClassesAtypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]

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