NDC 24338-530

SOTYLIZE

Sotalol Hydrochloride

SOTYLIZE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals, Inc.. The primary component is Sotalol Hydrochloride.

Product ID24338-530_a9f50c2c-41f4-44af-84c5-15def9b0f709
NDC24338-530
Product TypeHuman Prescription Drug
Proprietary NameSOTYLIZE
Generic NameSotalol Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-03-01
Marketing CategoryNDA / NDA
Application NumberNDA205108
Labeler NameArbor Pharmaceuticals, Inc.
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 24338-530-25

250 mL in 1 BOTTLE (24338-530-25)
Marketing Start Date2015-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 24338-530-48 [24338053048]

SOTYLIZE SOLUTION
Marketing CategoryNDA
Application NumberNDA205108
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-01

NDC 24338-530-25 [24338053025]

SOTYLIZE SOLUTION
Marketing CategoryNDA
Application NumberNDA205108
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-01

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:1f33f900-0777-4a92-a7f7-00cf3d57d95c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1593725
  • 1593731
    • UPC Code
  • 0324338530252

    • Pharmacological Class

    • Antiarrhythmic [EPC]
    • Cardiac Rhythm Alteration [PE]
    • Adrenergic beta-Antagonists [MoA]
    • Antiarrhythmic [EPC]
    • Cardiac Rhythm Alteration [PE]
    • Adrenergic beta-Antagonists [MoA]

    NDC Crossover Matching brand name "SOTYLIZE" or generic name "Sotalol Hydrochloride"

    NDCBrand NameGeneric Name
    24338-530SOTYLIZESOTYLIZE
    0245-0012SorineSotalol Hydrochloride
    0245-0013SorineSotalol Hydrochloride
    0245-0014SorineSotalol Hydrochloride
    0245-0015SorineSotalol Hydrochloride
    10135-661SotalolSotalol Hydrochloride
    10135-662SotalolSotalol Hydrochloride
    10135-663SotalolSotalol Hydrochloride
    0093-1060Sotalol HydrochlorideSotalol Hydrochloride
    0093-1061Sotalol HydrochlorideSotalol Hydrochloride
    0093-1062Sotalol HydrochlorideSotalol Hydrochloride
    0093-1063Sotalol HydrochlorideSotalol Hydrochloride
    0185-0170sotalol hydrochloridesotalol hydrochloride
    0185-0171sotalol hydrochloridesotalol hydrochloride
    0185-0174sotalol hydrochloridesotalol hydrochloride
    0185-0177sotalol hydrochloridesotalol hydrochloride
    0378-5123Sotalol Hydrochloridesotalol hydrochloride
    0378-5124Sotalol Hydrochloridesotalol hydrochloride
    0378-5125Sotalol Hydrochloridesotalol hydrochloride
    0603-5769Sotalol HydrochlorideSotalol Hydrochloride
    0603-5770Sotalol HydrochlorideSotalol Hydrochloride
    0603-5771Sotalol HydrochlorideSotalol Hydrochloride
    0603-5772Sotalol HydrochlorideSotalol Hydrochloride
    0615-5552Sotalol HydrochlorideSotalol Hydrochloride
    0615-7888Sotalol HydrochlorideSotalol Hydrochloride
    0904-7143Sotalol HydrochlorideSotalol Hydrochloride

    Trademark Results [SOTYLIZE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOTYLIZE
    SOTYLIZE
    86147411 4728651 Live/Registered
    Arbor Pharmaceuticals, LLC
    2013-12-18
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