"68083-112-01" National Drug Code (NDC)

Amiodarone Hydrochloride 10 SYRINGE in 1 CARTON (68083-112-01) > 3 mL in 1 SYRINGE
(Gland Pharma Limited)

NDC Code68083-112-01
Package Description10 SYRINGE in 1 CARTON (68083-112-01) > 3 mL in 1 SYRINGE
Product NDC68083-112
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAmiodarone Hydrochloride
Non-Proprietary NameAmiodarone Hydrochloride
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20130715
Marketing Category NameANDA
Application NumberANDA077161
ManufacturerGland Pharma Limited
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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