sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 80 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-804
Product ID 63187-804_77e00163-ec11-4bba-b1f9-08313bf22310
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 63187804
Hyphenated Format 63187-804

Supplemental Identifiers

RxCUI
1923426
UPC
0363187804305
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
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63187-804-30)
  • 60 TABLET in 1 BOTTLE (63187-804-60)
  • 90 TABLET in 1 BOTTLE (63187-804-90)
source: ndc

Packages (3)

63187-804-30 30 TABLET in 1 BOTTLE (63187-804-30) 63187-804-60 60 TABLET in 1 BOTTLE (63187-804-60) 63187-804-90 90 TABLET in 1 BOTTLE (63187-804-90)

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": "77e00163-ec11-4bba-b1f9-08313bf22310", "openfda": {"upc": ["0363187804305"], "unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["517824b1-11be-40a9-9066-d1a6a32a2938"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63187-804-30)", "package_ndc": "63187-804-30", "marketing_start_date": "20170102"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63187-804-60)", "package_ndc": "63187-804-60", "marketing_start_date": "20170102"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63187-804-90)", "package_ndc": "63187-804-90", "marketing_start_date": "20170102"}], "brand_name": "Sotalol Hydrochloride", "product_id": "63187-804_77e00163-ec11-4bba-b1f9-08313bf22310", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "63187-804", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "80 mg/1"}], "application_number": "ANDA076140", "marketing_category": "ANDA", "marketing_start_date": "20030201", "listing_expiration_date": "20261231"}