sotylize

Generic: sotalol hydrochloride

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sotylize
Generic Name sotalol hydrochloride
Labeler azurity pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sotalol hydrochloride 5 mg/mL

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-530
Product ID 24338-530_73961d33-7149-49f3-8386-91f1b1758ca5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205108
Listing Expiration 2026-12-31
Marketing Start 2015-03-01

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 24338530
Hyphenated Format 24338-530

Supplemental Identifiers

RxCUI
1593725 1593731
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 sotylize (source: ndc)
Generic Name sotalol hydrochloride (source: ndc)
Application Number NDA205108 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 250 mL in 1 BOTTLE (24338-530-25)
  • 480 mL in 1 BOTTLE (24338-530-48)
source: ndc

Packages (2)

24338-530-25 250 mL in 1 BOTTLE (24338-530-25) 24338-530-48 480 mL in 1 BOTTLE (24338-530-48)

Ingredients (1)

sotalol hydrochloride (5 mg/mL)

Linked Drug Pages (1)

SOTYLIZE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "73961d33-7149-49f3-8386-91f1b1758ca5", "openfda": {"unii": ["HEC37C70XX"], "rxcui": ["1593725", "1593731"], "spl_set_id": ["1f33f900-0777-4a92-a7f7-00cf3d57d95c"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE (24338-530-25)", "package_ndc": "24338-530-25", "marketing_start_date": "20150301"}, {"sample": false, "description": "480 mL in 1 BOTTLE (24338-530-48)", "package_ndc": "24338-530-48", "marketing_start_date": "20150301"}], "brand_name": "SOTYLIZE", "product_id": "24338-530_73961d33-7149-49f3-8386-91f1b1758ca5", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Antiarrhythmic [EPC]", "Cardiac Rhythm Alteration [PE]"], "product_ndc": "24338-530", "generic_name": "SOTALOL HYDROCHLORIDE", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SOTYLIZE", "active_ingredients": [{"name": "SOTALOL HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA205108", "marketing_category": "NDA", "marketing_start_date": "20150301", "listing_expiration_date": "20261231"}