sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sotalol hydrochloride 120 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-725
Product ID 50268-725_47fc0908-1c7a-abc6-e063-6294a90a20b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076140
Listing Expiration 2027-12-31
Marketing Start 2021-03-04

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 50268725
Hyphenated Format 50268-725

Supplemental Identifiers

RxCUI
1923422 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
  • 120 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-725-15) / 1 TABLET in 1 BLISTER PACK (50268-725-11)
source: ndc

Packages (1)

50268-725-15 50 BLISTER PACK in 1 BOX (50268-725-15) / 1 TABLET in 1 BLISTER PACK (50268-725-11)

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": "47fc0908-1c7a-abc6-e063-6294a90a20b2", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1923422", "1923426"], "spl_set_id": ["bcbc1624-283e-732f-e053-2995a90a8f11"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-725-15)  / 1 TABLET in 1 BLISTER PACK (50268-725-11)", "package_ndc": "50268-725-15", "marketing_start_date": "20210304"}], "brand_name": "Sotalol Hydrochloride", "product_id": "50268-725_47fc0908-1c7a-abc6-e063-6294a90a20b2", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "50268-725", "generic_name": "Sotalol Hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA076140", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20271231"}