"70518-3107-0" National Drug Code (NDC)

Budesonide And Formoterol Fumarate Dihydrate 1 POUCH in 1 CARTON (70518-3107-0) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER
(REMEDYREPACK INC.)

NDC Code70518-3107-0
Package Description1 POUCH in 1 CARTON (70518-3107-0) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER
Product NDC70518-3107
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBudesonide And Formoterol Fumarate Dihydrate
Non-Proprietary NameBudesonide And Formoterol Fumarate Dihydrate
Dosage FormAEROSOL
UsageRESPIRATORY (INHALATION)
Start Marketing Date20210527
Marketing Category NameNDA AUTHORIZED GENERIC
Application NumberNDA021929
ManufacturerREMEDYREPACK INC.
Substance NameBUDESONIDE; FORMOTEROL FUMARATE
Strength160; 4.5
Strength Unitug/1; ug/1
Pharmacy ClassesAdrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]

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