sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1125
Product ID 71335-1125_255a18f8-d1d0-4868-ad37-d6a39991064f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076140
Listing Expiration 2026-12-31
Marketing Start 2003-02-01

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 713351125
Hyphenated Format 71335-1125

Supplemental Identifiers

RxCUI
1923422
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 ANDA076140 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71335-1125-1)
  • 30 TABLET in 1 BOTTLE (71335-1125-2)
  • 90 TABLET in 1 BOTTLE (71335-1125-3)
source: ndc

Packages (3)

71335-1125-1 60 TABLET in 1 BOTTLE (71335-1125-1) 71335-1125-2 30 TABLET in 1 BOTTLE (71335-1125-2) 71335-1125-3 90 TABLET in 1 BOTTLE (71335-1125-3)

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": "255a18f8-d1d0-4868-ad37-d6a39991064f", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923422"], "spl_set_id": ["27c73b70-99e8-40e8-8aa9-36d3addd3bb4"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1125-1)", "package_ndc": "71335-1125-1", "marketing_start_date": "20241031"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1125-2)", "package_ndc": "71335-1125-2", "marketing_start_date": "20190226"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1125-3)", "package_ndc": "71335-1125-3", "marketing_start_date": "20230914"}], "brand_name": "Sotalol Hydrochloride", "product_id": "71335-1125_255a18f8-d1d0-4868-ad37-d6a39991064f", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "71335-1125", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076140", "marketing_category": "ANDA", "marketing_start_date": "20030201", "listing_expiration_date": "20261231"}