sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 240 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-450
Product ID 51655-450_490ece67-ce5a-8020-e063-6394a90a9bac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076140
Listing Expiration 2027-12-31
Marketing Start 2023-06-14

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 51655450
Hyphenated Format 51655-450

Supplemental Identifiers

RxCUI
904589
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
  • 240 mg/1
source: ndc
Packaging
  • 50 TABLET in 1 BOTTLE, PLASTIC (51655-450-15)
source: ndc

Packages (1)

51655-450-15 50 TABLET in 1 BOTTLE, PLASTIC (51655-450-15)

Ingredients (1)

sotalol hydrochloride (240 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": "490ece67-ce5a-8020-e063-6394a90a9bac", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["904589"], "spl_set_id": ["fe82c866-03d4-e07b-e053-6394a90a8b1e"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (51655-450-15)", "package_ndc": "51655-450-15", "marketing_start_date": "20230614"}], "brand_name": "Sotalol Hydrochloride", "product_id": "51655-450_490ece67-ce5a-8020-e063-6394a90a9bac", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "51655-450", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "240 mg/1"}], "application_number": "ANDA076140", "marketing_category": "ANDA", "marketing_start_date": "20230614", "listing_expiration_date": "20271231"}