"71335-2810-1" National Drug Code (NDC)

Mirabegron 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2810-1)
(Bryant Ranch Prepack)

NDC Code71335-2810-1
Package Description90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2810-1)
Product NDC71335-2810
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMirabegron
Non-Proprietary NameMirabegron
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20240903
Marketing Category NameANDA
Application NumberANDA209485
ManufacturerBryant Ranch Prepack
Substance NameMIRABEGRON
Strength50
Strength Unitmg/1
Pharmacy ClassesAdrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], beta3-Adrenergic Agonist [EPC]

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