sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: oxford pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler oxford pharmaceuticals, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 160 mg/1

Manufacturer
Oxford Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69584-843
Product ID 69584-843_71c67f34-73e1-4e4c-9c72-56f4b9222a88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075563
Listing Expiration 2026-12-31
Marketing Start 2020-07-24

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 69584843
Hyphenated Format 69584-843

Supplemental Identifiers

RxCUI
904589 1923422 1923424 1923426
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 ANDA075563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69584-843-10)
source: ndc

Packages (1)

69584-843-10 100 TABLET in 1 BOTTLE (69584-843-10)

Ingredients (1)

sotalol hydrochloride (160 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": "71c67f34-73e1-4e4c-9c72-56f4b9222a88", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["904589", "1923422", "1923424", "1923426"], "spl_set_id": ["c8ac6351-b1e9-4dd2-82f2-5980814fda15"], "manufacturer_name": ["Oxford Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69584-843-10)", "package_ndc": "69584-843-10", "marketing_start_date": "20200724"}], "brand_name": "Sotalol Hydrochloride", "product_id": "69584-843_71c67f34-73e1-4e4c-9c72-56f4b9222a88", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "69584-843", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Oxford Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "160 mg/1"}], "application_number": "ANDA075563", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20261231"}