sotalol hydrochloride

Generic: sotalol hydrochloride

Labeler: altathera pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotalol hydrochloride
Generic Name sotalol hydrochloride
Labeler altathera pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

sotalol hydrochloride 15 mg/mL

Manufacturer
ALTATHERA Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69724-112
Product ID 69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022306
Listing Expiration 2026-12-31
Marketing Start 2015-10-15

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 69724112
Hyphenated Format 69724-112

Supplemental Identifiers

RxCUI
904630
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 NDA022306 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

69724-112-10 1 VIAL in 1 CARTON (69724-112-10) / 10 mL in 1 VIAL

Ingredients (1)

sotalol hydrochloride (15 mg/mL)

Linked Drug Pages (1)

Sotalol hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d155f318-ecbf-4392-90a1-4409c5b8d13f", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["904630"], "spl_set_id": ["ff3061ab-d930-4318-a5be-684e38be229e"], "manufacturer_name": ["ALTATHERA Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (69724-112-10)  / 10 mL in 1 VIAL", "package_ndc": "69724-112-10", "marketing_start_date": "20151015"}], "brand_name": "Sotalol hydrochloride", "product_id": "69724-112_d155f318-ecbf-4392-90a1-4409c5b8d13f", "dosage_form": "INJECTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "69724-112", "generic_name": "Sotalol hydrochloride", "labeler_name": "ALTATHERA Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sotalol hydrochloride", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "15 mg/mL"}], "application_number": "NDA022306", "marketing_category": "NDA", "marketing_start_date": "20151015", "listing_expiration_date": "20261231"}