Package 68546-475-56

Brand: austedo xr

Generic: deutetrabenazine
NDC Package

Package Facts

Identity

Package NDC 68546-475-56
Digits Only 6854647556
Product NDC 68546-475
Description

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-475-56)

Marketing

Marketing Status
Marketed Since 2024-05-29
Brand austedo xr
Generic deutetrabenazine
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "69071a25-792d-4eec-a12a-1bb30c8fc881", "openfda": {"upc": ["0368546172606", "0368546170602", "0368546171609"], "unii": ["P341G6W9NB"], "rxcui": ["1876910", "1876916", "1876918", "1876920", "1876922", "1876924", "2281114", "2281115", "2281116", "2281117", "2541518", "2541519", "2541520", "2630144", "2630147", "2630150", "2630153", "2630155", "2630157", "2630159", "2630160", "2683282", "2683285", "2683288", "2683291", "2683294", "2683297", "2683300", "2683303", "2686153", "2686156", "2686612", "2686613"], "spl_set_id": ["7ea3c60a-45c7-44cc-afc2-d87fa53993c0"], "manufacturer_name": ["Teva Neuroscience, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-475-56)", "package_ndc": "68546-475-56", "marketing_start_date": "20240529"}], "brand_name": "AUSTEDO XR", "product_id": "68546-475_69071a25-792d-4eec-a12a-1bb30c8fc881", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "product_ndc": "68546-475", "generic_name": "deutetrabenazine", "labeler_name": "Teva Neuroscience, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AUSTEDO XR", "active_ingredients": [{"name": "DEUTETRABENAZINE", "strength": "42 mg/1"}], "application_number": "NDA216354", "marketing_category": "NDA", "marketing_start_date": "20240529", "listing_expiration_date": "20261231"}