"0378-5125-01" National Drug Code (NDC)

Sotalol Hydrochloride 100 TABLET in 1 BOTTLE, PLASTIC (0378-5125-01)
(Mylan Pharmaceuticals Inc.)

NDC Code0378-5125-01
Package Description100 TABLET in 1 BOTTLE, PLASTIC (0378-5125-01)
Product NDC0378-5125
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameSotalol Hydrochloride
Non-Proprietary NameSotalol Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20070220
Marketing Category NameANDA
Application NumberANDA077616
ManufacturerMylan Pharmaceuticals Inc.
Substance NameSOTALOL HYDROCHLORIDE
Strength160
Strength Unitmg/1
Pharmacy ClassesAntiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]

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