"52584-616-03" National Drug Code (NDC)

Amiodarone Hydrochloride 1 VIAL, SINGLE-DOSE in 1 BAG (52584-616-03) > 3 mL in 1 VIAL, SINGLE-DOSE
(General Injectables and Vaccines, Inc.)

NDC Code52584-616-03
Package Description1 VIAL, SINGLE-DOSE in 1 BAG (52584-616-03) > 3 mL in 1 VIAL, SINGLE-DOSE
Product NDC52584-616
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20170607
Marketing Category NameANDA
Application NumberANDA075761
ManufacturerGeneral Injectables and Vaccines, Inc.
Substance NameAMIODARONE HYDROCHLORIDE
Strength50
Strength Unitmg/mL
Pharmacy ClassesCytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]

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