Package 81968-045-31

Brand: auvelity

Generic: dextromethorphan hydrobromide, bupropion hydrochloride
NDC Package Sample

Package Facts

Identity

Package NDC 81968-045-31
Digits Only 8196804531
Product NDC 81968-045
Description

1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2024-05-10
Brand auvelity
Generic dextromethorphan hydrobromide, bupropion hydrochloride
Sample Package Yes

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "02ca1e62-a4d4-4dc7-b2e8-908f926af1f2", "openfda": {"upc": ["0381968045303", "0381968045600", "0381968045310", "0381968045143"], "unii": ["ZG7E5POY8O", "9D2RTI9KYH"], "rxcui": ["2611260", "2611266"], "spl_set_id": ["dcefda7c-9a68-278e-e053-2995a90aec79"], "manufacturer_name": ["Axsome Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (81968-045-14)  / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "81968-045-14", "marketing_start_date": "20240918"}, {"sample": false, "description": "30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)", "package_ndc": "81968-045-30", "marketing_start_date": "20220818"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (81968-045-31)  / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "81968-045-31", "marketing_start_date": "20240510"}, {"sample": false, "description": "60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)", "package_ndc": "81968-045-60", "marketing_start_date": "20240628"}], "brand_name": "AUVELITY", "product_id": "81968-045_02ca1e62-a4d4-4dc7-b2e8-908f926af1f2", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "81968-045", "generic_name": "dextromethorphan hydrobromide, bupropion hydrochloride", "labeler_name": "Axsome Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AUVELITY", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "105 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "45 mg/1"}], "application_number": "NDA215430", "marketing_category": "NDA", "marketing_start_date": "20220818", "listing_expiration_date": "20261231"}