NDC 43353-616

Sotalol Hydrochloride

Sotalol Hydrochloride

Sotalol Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Sotalol Hydrochloride.

Product ID43353-616_c68dff8e-c8ac-4ed4-8700-a70b920554a8
NDC43353-616
Product TypeHuman Prescription Drug
Proprietary NameSotalol Hydrochloride
Generic NameSotalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-11-07
Marketing CategoryANDA / ANDA
Application NumberANDA075563
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-616-30

30 TABLET in 1 BOTTLE, PLASTIC (43353-616-30)
Marketing Start Date2010-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-616-60 [43353061660]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-10

NDC 43353-616-30 [43353061630]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-10

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:28ba5f2a-ed6b-49a7-8a11-2d811ce9d946
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923426

    • 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 "Sotalol Hydrochloride" or generic name "Sotalol Hydrochloride"

    NDCBrand NameGeneric Name
    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
    68071-2014Sotalol HydrochlorideSotalol Hydrochloride
    68084-654Sotalol HydrochlorideSotalol Hydrochloride
    68151-2702Sotalol HydrochlorideSotalol Hydrochloride
    69724-112Sotalol hydrochlorideSotalol hydrochloride
    71205-046Sotalol HydrochlorideSotalol Hydrochloride
    71335-0260Sotalol HydrochlorideSotalol Hydrochloride
    71335-0860Sotalol HydrochlorideSotalol Hydrochloride
    71610-074Sotalol HydrochlorideSotalol Hydrochloride
    21695-397sotalol hydrochloridesotalol hydrochloride
    42806-121Sotalol HydrochlorideSotalol Hydrochloride
    43063-133sotalol hydrochloridesotalol hydrochloride
    42806-122Sotalol HydrochlorideSotalol Hydrochloride
    42806-123Sotalol HydrochlorideSotalol Hydrochloride
    43353-616Sotalol HydrochlorideSotalol Hydrochloride
    50090-1299Sotalol HydrochlorideSotalol Hydrochloride
    53217-011Sotalol HydrochlorideSotalol Hydrochloride
    60429-751Sotalol HydrochlorideSotalol Hydrochloride
    60505-0222Sotalol HydrochlorideSotalol Hydrochloride
    60505-0081Sotalol HydrochlorideSotalol Hydrochloride
    60505-0224Sotalol HydrochlorideSotalol Hydrochloride
    60505-0080Sotalol HydrochlorideSotalol Hydrochloride
    60429-749Sotalol HydrochlorideSotalol Hydrochloride
    60505-0223Sotalol HydrochlorideSotalol Hydrochloride
    60429-748Sotalol HydrochlorideSotalol Hydrochloride
    60429-750Sotalol HydrochlorideSotalol Hydrochloride
    60505-0082Sotalol HydrochlorideSotalol Hydrochloride
    60505-0159Sotalol HydrochlorideSotalol Hydrochloride
    63187-426Sotalol HydrochlorideSotalol Hydrochloride
    63187-804Sotalol HydrochlorideSotalol Hydrochloride
    63629-4719Sotalol HydrochlorideSotalol Hydrochloride
    71335-1125Sotalol HydrochlorideSotalol Hydrochloride
    71610-294Sotalol HydrochlorideSotalol Hydrochloride
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