Package 76385-125-01

Brand: sotalol hydrochloride af

Generic: sotalol hydrochloride tables af
NDC Package

Package Facts

Identity

Package NDC 76385-125-01
Digits Only 7638512501
Product NDC 76385-125
Description

100 TABLET in 1 BOTTLE, PLASTIC (76385-125-01)

Marketing

Marketing Status
Marketed Since 2020-02-21
Brand sotalol hydrochloride af
Generic sotalol hydrochloride tables af
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "fe9ac463-547d-4917-a98e-61f1c0fe38f1", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922763", "1922765", "1923422", "1923424", "1923426"], "spl_set_id": ["56879738-8662-4f5c-8386-761ab2b5e46f"], "manufacturer_name": ["UNICHEM PHARMACEUTICALS (USA), INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (76385-125-01)", "package_ndc": "76385-125-01", "marketing_start_date": "20200221"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (76385-125-50)", "package_ndc": "76385-125-50", "marketing_start_date": "20200221"}], "brand_name": "Sotalol Hydrochloride AF", "product_id": "76385-125_fe9ac463-547d-4917-a98e-61f1c0fe38f1", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "76385-125", "generic_name": "Sotalol Hydrochloride Tables AF", "labeler_name": "UNICHEM PHARMACEUTICALS (USA), INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "brand_name_suffix": "AF", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA207429", "marketing_category": "ANDA", "marketing_start_date": "20200221", "listing_expiration_date": "20271231"}