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 80 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-1917
Product ID 71335-1917_7da2dbe1-dd39-487c-99ee-59ff2fae4eb2
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 713351917
Hyphenated Format 71335-1917

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 (71335-1917-1)
  • 30 TABLET in 1 BOTTLE (71335-1917-2)
  • 100 TABLET in 1 BOTTLE (71335-1917-3)
  • 90 TABLET in 1 BOTTLE (71335-1917-4)
source: ndc

Packages (4)

71335-1917-1 60 TABLET in 1 BOTTLE (71335-1917-1) 71335-1917-2 30 TABLET in 1 BOTTLE (71335-1917-2) 71335-1917-3 100 TABLET in 1 BOTTLE (71335-1917-3) 71335-1917-4 90 TABLET in 1 BOTTLE (71335-1917-4)

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": "7da2dbe1-dd39-487c-99ee-59ff2fae4eb2", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["2f13a6dd-dd77-47c8-ac5d-4a746c32dbd0"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1917-1)", "package_ndc": "71335-1917-1", "marketing_start_date": "20220706"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1917-2)", "package_ndc": "71335-1917-2", "marketing_start_date": "20210722"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-1917-3)", "package_ndc": "71335-1917-3", "marketing_start_date": "20210722"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1917-4)", "package_ndc": "71335-1917-4", "marketing_start_date": "20220706"}], "brand_name": "Sotalol Hydrochloride", "product_id": "71335-1917_7da2dbe1-dd39-487c-99ee-59ff2fae4eb2", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "71335-1917", "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": "80 mg/1"}], "application_number": "ANDA075563", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20261231"}