"76385-115-01" National Drug Code (NDC)

Sotalol 100 TABLET in 1 BOTTLE, PLASTIC (76385-115-01)
(Bayshore Pharmaceuticals LLC)

NDC Code76385-115-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (76385-115-01)
Product NDC76385-115
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSotalol
Non-Proprietary NameSotalol Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20171206
Marketing Category NameANDA
Application NumberANDA207428
ManufacturerBayshore Pharmaceuticals LLC
Substance NameSOTALOL HYDROCHLORIDE
Strength120
Strength Unitmg/1
Pharmacy ClassesAdrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]

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