NDC 76385-127

Sotalol Hydrochloride AF

Sotalol Hydrochloride Tablets Af

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

Product ID76385-127_ac802362-6c2c-4360-b975-4dea4d0379fa
NDC76385-127
Product TypeHuman Prescription Drug
Proprietary NameSotalol Hydrochloride AF
Generic NameSotalol Hydrochloride Tablets Af
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-02-21
Marketing CategoryANDA / ANDA
Application NumberANDA207429
Labeler NameBayshore Pharmaceuticals LLC
Substance NameSOTALOL HYDROCHLORIDE
Active Ingredient Strength160 mg/1
Pharm ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76385-127-01

100 TABLET in 1 BOTTLE, PLASTIC (76385-127-01)
Marketing Start Date2020-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76385-127-50 [76385012750]

Sotalol Hydrochloride AF TABLET
Marketing CategoryANDA
Application NumberANDA207429
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-21

NDC 76385-127-01 [76385012701]

Sotalol Hydrochloride AF TABLET
Marketing CategoryANDA
Application NumberANDA207429
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-21

Drug Details

Active Ingredients

IngredientStrength
SOTALOL HYDROCHLORIDE160 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "Sotalol Hydrochloride AF" or generic name "Sotalol Hydrochloride Tablets Af"

NDCBrand NameGeneric Name
76385-125Sotalol Hydrochloride AFSotalol Hydrochloride AF
76385-126Sotalol Hydrochloride AFSotalol Hydrochloride AF
10135-716Sotalol Hydrochloride AFSotalol Hydrochloride AF
10135-715Sotalol Hydrochloride AFSotalol Hydrochloride AF
10135-717Sotalol Hydrochloride AFSotalol Hydrochloride AF
76385-127Sotalol HydrochlorideSotalol Hydrochloride Tablets AF

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.