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"63323-616-03" National Drug Code (NDC)

Amiodarone Hydrochloride 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01)
(Fresenius Kabi USA, LLC)

NDC Code63323-616-03
Package Description25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01)
Product NDC63323-616
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20030128
Marketing Category NameANDA
Application NumberANDA075761
ManufacturerFresenius Kabi USA, LLC
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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