sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 80 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7796
Product ID 50090-7796_4d187dd3-c6fd-4e9a-a56a-b42b9f1d8882
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 500907796
Hyphenated Format 50090-7796

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
  • 60 TABLET in 1 BOTTLE (50090-7796-0)
  • 90 TABLET in 1 BOTTLE (50090-7796-2)
source: ndc

Packages (2)

50090-7796-0 60 TABLET in 1 BOTTLE (50090-7796-0) 50090-7796-2 90 TABLET in 1 BOTTLE (50090-7796-2)

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": "4d187dd3-c6fd-4e9a-a56a-b42b9f1d8882", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["bbeaba9f-0513-4980-bc29-7f9259a53ecc"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-7796-0)", "package_ndc": "50090-7796-0", "marketing_start_date": "20251125"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-7796-2)", "package_ndc": "50090-7796-2", "marketing_start_date": "20251203"}], "brand_name": "Sotalol Hydrochloride", "product_id": "50090-7796_4d187dd3-c6fd-4e9a-a56a-b42b9f1d8882", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "50090-7796", "generic_name": "Sotalol Hydrochloride", "labeler_name": "A-S Medication Solutions", "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"}