NDC 10135-661

Sotalol

Sotalol Hydrochloride

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

Product ID10135-661_43615ac7-ce53-4272-a0b7-32b614c19eb6
NDC10135-661
Product TypeHuman Prescription Drug
Proprietary NameSotalol
Generic NameSotalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA207428
Labeler NameMarlex Pharmaceuticals Inc
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10135-661-01

100 TABLET in 1 BOTTLE, PLASTIC (10135-661-01)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-661-01 [10135066101]

Sotalol TABLET
Marketing CategoryANDA
Application NumberANDA207428
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-20

NDC 10135-661-50 [10135066150]

Sotalol TABLET
Marketing CategoryANDA
Application NumberANDA207428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31
Reactivation Date2020-02-20

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:3c24cdf0-4648-4e5d-993c-1f428ce56a65
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923424
  • 1923426
  • 1923422
  • UPC Code
  • 0310135662012
  • 0310135661015
  • 0310135663019
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    10135-661SotalolSotalol Hydrochloride
    10135-662SotalolSotalol Hydrochloride
    10135-663SotalolSotalol Hydrochloride
    76385-116SotalolSotalol
    76385-114SotalolSotalol
    76385-115SotalolSotalol
    71335-1189SotalolSotalol
    71610-385SotalolSotalol
    0245-0012SorineSotalol Hydrochloride
    0245-0013SorineSotalol Hydrochloride
    0245-0014SorineSotalol Hydrochloride
    0245-0015SorineSotalol 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

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