sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 80 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-889
Product ID 71610-889_314047e7-4b8f-27ac-e063-6294a90a2b83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075429
Listing Expiration 2026-12-31
Marketing Start 2000-05-04

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 71610889
Hyphenated Format 71610-889

Supplemental Identifiers

RxCUI
1923426
UNII
HEC37C70XX

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 ANDA075429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (71610-889-80)
source: ndc

Packages (1)

71610-889-80 180 TABLET in 1 BOTTLE (71610-889-80)

Ingredients (1)

sotalol hydrochloride (80 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": "314047e7-4b8f-27ac-e063-6294a90a2b83", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["31404462-7fa0-20d6-e063-6294a90aa58c"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-889-80)", "package_ndc": "71610-889-80", "marketing_start_date": "20250321"}], "brand_name": "Sotalol Hydrochloride", "product_id": "71610-889_314047e7-4b8f-27ac-e063-6294a90a2b83", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "71610-889", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA075429", "marketing_category": "ANDA", "marketing_start_date": "20000504", "listing_expiration_date": "20261231"}