NDC 71335-1189

Sotalol

Sotalol Hydrochloride

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

Product ID71335-1189_c824f6b2-80c5-45a6-a491-4c14c9f5e33d
NDC71335-1189
Product TypeHuman Prescription Drug
Proprietary NameSotalol
Generic NameSotalol Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA207428
Labeler NameBryant Ranch Prepack
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength80 mg/1
Pharm ClassesAdrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1189-1

60 TABLET in 1 BOTTLE (71335-1189-1)
Marketing Start Date2019-04-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1189-1 [71335118901]

Sotalol TABLET
Marketing CategoryANDA
Application NumberANDA207428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 71335-1189-2 [71335118902]

Sotalol TABLET
Marketing CategoryANDA
Application NumberANDA207428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 71335-1189-3 [71335118903]

Sotalol TABLET
Marketing CategoryANDA
Application NumberANDA207428
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE80 mg/1

OpenFDA Data

SPL SET ID:c824f6b2-80c5-45a6-a491-4c14c9f5e33d
Manufacturer
UNII

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" 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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