sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 80 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7143
Product ID 0904-7143_2b64f084-8d8f-454c-834b-16e8d1439c77
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 09047143
Hyphenated Format 0904-7143

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 ANDA076140 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7143-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7143-61 100 BLISTER PACK in 1 CARTON (0904-7143-61) / 1 TABLET in 1 BLISTER PACK

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": "2b64f084-8d8f-454c-834b-16e8d1439c77", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923426"], "spl_set_id": ["866e5717-3de2-4f19-b7c7-2275caeef78b"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7143-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7143-61", "marketing_start_date": "20030201"}], "brand_name": "Sotalol Hydrochloride", "product_id": "0904-7143_2b64f084-8d8f-454c-834b-16e8d1439c77", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "0904-7143", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Major Pharmaceuticals", "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"}