Package 83107-005-10

Brand: betapace

Generic: sotalol hydrochloride
NDC Package

Package Facts

Identity

Package NDC 83107-005-10
Digits Only 8310700510
Product NDC 83107-005
Description

100 TABLET in 1 BOTTLE (83107-005-10)

Marketing

Marketing Status
Marketed Since 2016-09-01
Brand betapace
Generic sotalol hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e", "openfda": {"upc": ["0383107008606", "0383107009603", "0383107006107", "0383107007104", "0383107010609", "0383107005100"], "unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922721", "1922763", "1922764", "1922765", "1922766", "1923422", "1923423", "1923424", "1923425", "1923426", "1923427"], "spl_set_id": ["a6a7702f-36c9-45db-b640-453dc324baee"], "manufacturer_name": ["Legacy Pharma USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (83107-005-10)", "package_ndc": "83107-005-10", "marketing_start_date": "20160901"}], "brand_name": "BETAPACE", "product_id": "83107-005_fcc2fc9c-87b2-4f9f-8d4d-b1f10214884e", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "83107-005", "generic_name": "sotalol hydrochloride", "labeler_name": "Legacy Pharma USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BETAPACE", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "NDA019865", "marketing_category": "NDA", "marketing_start_date": "20160901", "listing_expiration_date": "20261231"}