"0574-0840-01" National Drug Code (NDC)

Ibutilide Fumarate 1 VIAL, SINGLE-DOSE in 1 CARTON (0574-0840-01) > 10 mL in 1 VIAL, SINGLE-DOSE
(Paddock Laboratories, Inc.)

NDC Code0574-0840-01
Package Description1 VIAL, SINGLE-DOSE in 1 CARTON (0574-0840-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC0574-0840
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameIbutilide Fumarate
Non-Proprietary NameIbutilide Fumarate
Dosage FormINJECTION, SOLUTION
UsageINTRAVENOUS
Start Marketing Date20100113
Marketing Category NameANDA
Application NumberANDA090240
ManufacturerPaddock Laboratories, Inc.
Substance NameIBUTILIDE FUMARATE
Strength.1
Strength Unitmg/mL
Pharmacy ClassesAntiarrhythmic [EPC]

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