sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 160 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-777
Product ID 59651-777_8a142042-e510-4232-8f20-5c92a991bd91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077616
Listing Expiration 2026-12-31
Marketing Start 2023-06-29

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 59651777
Hyphenated Format 59651-777

Supplemental Identifiers

RxCUI
1922720 1922763 1922765
UNII
HEC37C70XX

Packaging Origin

Original Packager
true

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 ANDA077616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-777-01)
source: ndc

Packages (1)

59651-777-01 100 TABLET in 1 BOTTLE (59651-777-01)

Ingredients (1)

sotalol hydrochloride (160 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": "8a142042-e510-4232-8f20-5c92a991bd91", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922763", "1922765"], "spl_set_id": ["6f3145d7-f3c9-4456-a77d-d04c54f24668"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-777-01)", "package_ndc": "59651-777-01", "marketing_start_date": "20230629"}], "brand_name": "SOTALOL HYDROCHLORIDE", "product_id": "59651-777_8a142042-e510-4232-8f20-5c92a991bd91", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "59651-777", "generic_name": "SOTALOL HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOTALOL HYDROCHLORIDE", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "160 mg/1"}], "application_number": "ANDA077616", "marketing_category": "ANDA", "marketing_start_date": "20230629", "listing_expiration_date": "20261231"}