"67184-0571-1" National Drug Code (NDC)

Mirabegron 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0571-1)
(Qilu Pharmaceutical Co., Ltd.)

NDC Code67184-0571-1
Package Description30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67184-0571-1)
Product NDC67184-0571
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMirabegron
Non-Proprietary NameMirabegron
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20250630
Marketing Category NameANDA
Application NumberANDA217989
ManufacturerQilu Pharmaceutical Co., Ltd.
Substance NameMIRABEGRON
Strength25
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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