sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

sotalol hydrochloride 120 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-138
Product ID 72789-138_40a68ec8-c1d1-cc50-e063-6394a90aacca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075563
Listing Expiration 2026-12-31
Marketing Start 2020-07-24

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 72789138
Hyphenated Format 72789-138

Supplemental Identifiers

RxCUI
904589 1923422 1923424 1923426
UPC
0372789137018 0372789138015 0372789136011 0372789135014
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 ANDA075563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-138-01)
source: ndc

Packages (1)

72789-138-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-138-01)

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": "40a68ec8-c1d1-cc50-e063-6394a90aacca", "openfda": {"upc": ["0372789137018", "0372789138015", "0372789136011", "0372789135014"], "unii": ["HEC37C70XX"], "rxcui": ["904589", "1923422", "1923424", "1923426"], "spl_set_id": ["e6ea445d-4d7c-4c32-83a7-e7683a56075b"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-138-01)", "package_ndc": "72789-138-01", "marketing_start_date": "20201106"}], "brand_name": "Sotalol Hydrochloride", "product_id": "72789-138_40a68ec8-c1d1-cc50-e063-6394a90aacca", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "72789-138", "generic_name": "Sotalol Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol Hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "120 mg/1"}], "application_number": "ANDA075563", "marketing_category": "ANDA", "marketing_start_date": "20200724", "listing_expiration_date": "20261231"}