"51862-580-01" National Drug Code (NDC)

Budesonide (enteric Coated) 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)
(Mayne Pharma Inc.)

NDC Code51862-580-01
Package Description100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51862-580-01)
Product NDC51862-580
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBudesonide (enteric Coated)
Non-Proprietary NameBudesonide
Dosage FormCAPSULE, DELAYED RELEASE PELLETS
UsageORAL
Start Marketing Date20191031
Marketing Category NameANDA
Application NumberANDA206623
ManufacturerMayne Pharma Inc.
Substance NameBUDESONIDE
Strength3
Strength Unitmg/1
Pharmacy ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]

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