sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler epic pharma, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-122
Product ID 42806-122_34ed0846-81bd-46c4-a57c-b617c7d8232d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077070
Listing Expiration 2026-12-31
Marketing Start 2016-01-04

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 42806122
Hyphenated Format 42806-122

Supplemental Identifiers

RxCUI
1922720 1922763 1922765
UPC
0342806121016 0342806122013
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 ANDA077070 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42806-122-01)
  • 1000 TABLET in 1 BOTTLE (42806-122-10)
source: ndc

Packages (2)

42806-122-01 100 TABLET in 1 BOTTLE (42806-122-01) 42806-122-10 1000 TABLET in 1 BOTTLE (42806-122-10)

Ingredients (1)

sotalol hydrochloride (120 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": "34ed0846-81bd-46c4-a57c-b617c7d8232d", "openfda": {"upc": ["0342806121016", "0342806122013"], "unii": ["HEC37C70XX"], "rxcui": ["1922720", "1922763", "1922765"], "spl_set_id": ["c0a34c56-9641-4592-9754-bcc233ec86b6"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42806-122-01)", "package_ndc": "42806-122-01", "marketing_start_date": "20160104"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (42806-122-10)", "package_ndc": "42806-122-10", "marketing_start_date": "20160104"}], "brand_name": "Sotalol hydrochloride", "product_id": "42806-122_34ed0846-81bd-46c4-a57c-b617c7d8232d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "42806-122", "generic_name": "sotalol hydrochloride", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA077070", "marketing_category": "ANDA", "marketing_start_date": "20160104", "listing_expiration_date": "20261231"}