"70771-1753-9" National Drug Code (NDC)

Mirabegron 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-9)
(Zydus Lifesciences Limited)

NDC Code70771-1753-9
Package Description90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1753-9)
Product NDC70771-1753
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMirabegron
Non-Proprietary NameMirabegron
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20240123
Marketing Category NameANDA
Application NumberANDA209488
ManufacturerZydus Lifesciences Limited
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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