"68382-227-10" National Drug Code (NDC)

Amiodarone Hydrochloride 1000 TABLET in 1 BOTTLE (68382-227-10)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-227-10
Package Description1000 TABLET in 1 BOTTLE (68382-227-10)
Product NDC68382-227
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormTABLET
UsageORAL
Start Marketing Date20090810
Marketing Category NameANDA
Application NumberANDA079029
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameAMIODARONE HYDROCHLORIDE
Strength200
Strength Unitmg/1
Pharmacy ClassesAntiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]

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