sotalol

Generic: sotalol hydrochloride

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

Drug Facts

Product Profile

Brand Name sotalol
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 71335-1189
Product ID 71335-1189_ca49d506-4490-469e-8084-b687dd488a88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207428
Listing Expiration 2026-12-31
Marketing Start 2017-12-15

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 713351189
Hyphenated Format 71335-1189

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 (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number ANDA207428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71335-1189-1)
  • 30 TABLET in 1 BOTTLE (71335-1189-2)
  • 100 TABLET in 1 BOTTLE (71335-1189-3)
  • 90 TABLET in 1 BOTTLE (71335-1189-4)
source: ndc

Packages (4)

71335-1189-1 60 TABLET in 1 BOTTLE (71335-1189-1) 71335-1189-2 30 TABLET in 1 BOTTLE (71335-1189-2) 71335-1189-3 100 TABLET in 1 BOTTLE (71335-1189-3) 71335-1189-4 90 TABLET in 1 BOTTLE (71335-1189-4)

Ingredients (1)

sotalol hydrochloride (80 mg/1)

Linked Drug Pages (1)

Sotalol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ca49d506-4490-469e-8084-b687dd488a88", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["c824f6b2-80c5-45a6-a491-4c14c9f5e33d"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71335-1189-1)", "package_ndc": "71335-1189-1", "marketing_start_date": "20190415"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71335-1189-2)", "package_ndc": "71335-1189-2", "marketing_start_date": "20190422"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (71335-1189-3)", "package_ndc": "71335-1189-3", "marketing_start_date": "20240517"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71335-1189-4)", "package_ndc": "71335-1189-4", "marketing_start_date": "20240517"}], "brand_name": "Sotalol", "product_id": "71335-1189_ca49d506-4490-469e-8084-b687dd488a88", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "71335-1189", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA207428", "marketing_category": "ANDA", "marketing_start_date": "20171215", "listing_expiration_date": "20261231"}