"70518-4304-0" National Drug Code (NDC)

Mirabegron 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)
(REMEDYREPACK INC.)

NDC Code70518-4304-0
Package Description90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)
Product NDC70518-4304
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMirabegron
Non-Proprietary NameMirabegron
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20250307
Marketing Category NameANDA
Application NumberANDA209488
ManufacturerREMEDYREPACK INC.
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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