sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler apotex corp.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0223
Product ID 60505-0223_7e1fd07e-45aa-ef32-da1b-c81f6961f216
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076214
Listing Expiration 2026-12-31
Marketing Start 2003-09-09

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] antiarrhythmic [epc] cardiac rhythm alteration [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605050223
Hyphenated Format 60505-0223

Supplemental Identifiers

RxCUI
904589 1922720 1922763 1922765 1923422 1923424 1923426
UPC
0360505015900 0360505008209
UNII
HEC37C70XX

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sotalol hydrochloride (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number ANDA076214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (60505-0223-1)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (60505-0223-2)
source: ndc

Packages (2)

60505-0223-1 100 TABLET in 1 BOTTLE, PLASTIC (60505-0223-1) 60505-0223-2 1000 TABLET in 1 BOTTLE, PLASTIC (60505-0223-2)

Ingredients (1)

sotalol hydrochloride (120 mg/1)

Linked Drug Pages (1)

Sotalol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7e1fd07e-45aa-ef32-da1b-c81f6961f216", "openfda": {"upc": ["0360505015900", "0360505008209"], "unii": ["HEC37C70XX"], "rxcui": ["904589", "1922720", "1922763", "1922765", "1923422", "1923424", "1923426"], "spl_set_id": ["1a56c82e-7ecd-43b0-2899-f89e47adf7db"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (60505-0223-1)", "package_ndc": "60505-0223-1", "marketing_start_date": "20030909"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (60505-0223-2)", "package_ndc": "60505-0223-2", "marketing_start_date": "20030909"}], "brand_name": "Sotalol Hydrochloride", "product_id": "60505-0223_7e1fd07e-45aa-ef32-da1b-c81f6961f216", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "60505-0223", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076214", "marketing_category": "ANDA", "marketing_start_date": "20030909", "listing_expiration_date": "20261231"}