Package 65757-654-42

Brand: lybalvi

Generic: olanzapine and samidorphan l-malate
NDC Package

Package Facts

Identity

Package NDC 65757-654-42
Digits Only 6575765442
Product NDC 65757-654
Description

1 BOTTLE in 1 CARTON (65757-654-42) / 30 TABLET, FILM COATED in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2021-09-20
Brand lybalvi
Generic olanzapine and samidorphan l-malate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "44ae69cc-b9a6-4658-90fa-1dbef1e97eb4", "openfda": {"nui": ["N0000175430"], "unii": ["0AJQ5N56E0", "N7U69T4SZR"], "rxcui": ["2570392", "2570398", "2570399", "2570401", "2570402", "2570404", "2570405", "2570407"], "spl_set_id": ["32ffddd1-4e2b-45d9-9b36-bb730167ec80"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Alkermes, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (65757-654-41)  / 7 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65757-654-41", "marketing_start_date": "20210920"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65757-654-42)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65757-654-42", "marketing_start_date": "20210920"}], "brand_name": "LYBALVI", "product_id": "65757-654_44ae69cc-b9a6-4658-90fa-1dbef1e97eb4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]", "Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "65757-654", "generic_name": "olanzapine and samidorphan L-malate", "labeler_name": "Alkermes, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LYBALVI", "active_ingredients": [{"name": "OLANZAPINE", "strength": "20 mg/1"}, {"name": "SAMIDORPHAN L-MALATE", "strength": "10 mg/1"}], "application_number": "NDA213378", "marketing_category": "NDA", "marketing_start_date": "20210920", "listing_expiration_date": "20271231"}