"52584-063-01" National Drug Code (NDC)

Amiodarone Hydrochloride 1 VIAL, SINGLE-DOSE in 1 BAG (52584-063-01) > 3 mL in 1 VIAL, SINGLE-DOSE
(General Injectables and Vaccines, Inc.)

NDC Code52584-063-01
Package Description1 VIAL, SINGLE-DOSE in 1 BAG (52584-063-01) > 3 mL in 1 VIAL, SINGLE-DOSE
Product NDC52584-063
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20180611
End Marketing Date20220430
Marketing Category NameANDA
Application NumberANDA077234
ManufacturerGeneral Injectables and Vaccines, Inc.
Substance NameAMIODARONE HYDROCHLORIDE
Strength50
Strength Unitmg/mL
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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