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 71610-474
Product ID 71610-474_c2c1a3a6-f70e-4b47-85b6-e4d10c110588
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 71610474
Hyphenated Format 71610-474

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 ANDA075563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-474-60)
  • 180 TABLET in 1 BOTTLE (71610-474-80)
source: ndc

Packages (2)

71610-474-60 90 TABLET in 1 BOTTLE (71610-474-60) 71610-474-80 180 TABLET in 1 BOTTLE (71610-474-80)

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": "c2c1a3a6-f70e-4b47-85b6-e4d10c110588", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["253da1e1-022a-4175-bd7f-e7673cba0767"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-474-60)", "package_ndc": "71610-474-60", "marketing_start_date": "20220125"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71610-474-80)", "package_ndc": "71610-474-80", "marketing_start_date": "20201015"}], "brand_name": "Sotalol Hydrochloride", "product_id": "71610-474_c2c1a3a6-f70e-4b47-85b6-e4d10c110588", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "71610-474", "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": "ANDA075563", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20261231"}