NDC 0603-5769

Sotalol Hydrochloride

Sotalol Hydrochloride

Sotalol Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Sotalol Hydrochloride.

Product ID0603-5769_2398995d-e533-4306-a436-eb87ff0f064f
NDC0603-5769
Product TypeHuman Prescription Drug
Proprietary NameSotalol Hydrochloride
Generic NameSotalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-11-07
Marketing End Date2019-06-30
Marketing CategoryANDA / ANDA
Application NumberANDA075563
Labeler NamePar Pharmaceutical
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN

Packaging

NDC 0603-5769-21

100 TABLET in 1 BOTTLE, PLASTIC (0603-5769-21)
Marketing Start Date2003-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-5769-28 [00603576928]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-11-07
Marketing End Date2019-06-30

NDC 0603-5769-10 [00603576910]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-11-07
Marketing End Date2015-08-29

NDC 0603-5769-21 [00603576921]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-11-07
Marketing End Date2019-04-30

NDC 0603-5769-32 [00603576932]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-11-07
Marketing End Date2015-08-29

NDC 0603-5769-29 [00603576929]

Sotalol Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA075563
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-11-07
Marketing End Date2015-08-29

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:576905b7-6e6d-4aa0-b690-24be26e70cd2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923424
  • 1923426
  • 904589
  • 1923422
    • UPC Code
  • 0306035769210
  • 0306035772210
  • 0306035770216
  • 0306035771213

    • Pharmacological Class

    • 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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