"52584-348-35" National Drug Code (NDC)

Amiodarone Hydrochloride 1 AMPULE in 1 BAG (52584-348-35) > 3 mL in 1 AMPULE
(General Injectables & Vaccines, Inc.)

NDC Code52584-348-35
Package Description1 AMPULE in 1 BAG (52584-348-35) > 3 mL in 1 AMPULE
Product NDC52584-348
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormINJECTION, SOLUTION, CONCENTRATE
UsageINTRAVENOUS
Start Marketing Date20100301
Marketing Category NameANDA
Application NumberANDA075955
ManufacturerGeneral Injectables & Vaccines, Inc.
Substance NameAMIODARONE HYDROCHLORIDE
Strength50
Strength Unitmg/mL
Pharmacy ClassesAntiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]

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