"70518-4613-0" National Drug Code (NDC)

Budesonide 50 POUCH in 1 BOX (70518-4613-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4613-1)
(REMEDYREPACK INC.)

NDC Code70518-4613-0
Package Description50 POUCH in 1 BOX (70518-4613-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4613-1)
Product NDC70518-4613
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBudesonide
Non-Proprietary NameBudesonide
Dosage FormCAPSULE, COATED PELLETS
UsageORAL
Start Marketing Date20260423
Marketing Category NameANDA
Application NumberANDA206134
ManufacturerREMEDYREPACK INC.
Substance NameBUDESONIDE
Strength3
Strength Unitmg/1
Pharmacy ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]

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