sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-1060
Product ID 0093-1060_b0c7f185-187e-443c-9ca8-7ff9658bf713
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075429
Listing Expiration 2026-12-31
Marketing Start 2000-05-05

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 00931060
Hyphenated Format 0093-1060

Supplemental Identifiers

RxCUI
904589 1923422 1923424 1923426
UPC
0300931062017 0300931060013 0300931063014 0300931061010
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 ANDA075429 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0093-1060-01)
source: ndc

Packages (1)

0093-1060-01 100 TABLET in 1 BOTTLE (0093-1060-01)

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": "b0c7f185-187e-443c-9ca8-7ff9658bf713", "openfda": {"upc": ["0300931062017", "0300931060013", "0300931063014", "0300931061010"], "unii": ["HEC37C70XX"], "rxcui": ["904589", "1923422", "1923424", "1923426"], "spl_set_id": ["8e2772cb-7dea-42d1-ba31-d479ba7cb09a"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0093-1060-01)", "package_ndc": "0093-1060-01", "marketing_start_date": "20000505"}], "brand_name": "Sotalol Hydrochloride", "product_id": "0093-1060_b0c7f185-187e-443c-9ca8-7ff9658bf713", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "0093-1060", "generic_name": "Sotalol Hydrochloride", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075429", "marketing_category": "ANDA", "marketing_start_date": "20000505", "listing_expiration_date": "20261231"}