"68180-151-06" National Drug Code (NDC)

Mirabegron 1 BOTTLE in 1 CARTON (68180-151-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
(Lupin Pharmaceuticals, Inc.)

NDC Code68180-151-06
Package Description1 BOTTLE in 1 CARTON (68180-151-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product NDC68180-151
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMirabegron
Non-Proprietary NameMirabegron
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20240419
Marketing Category NameANDA
Application NumberANDA209485
ManufacturerLupin Pharmaceuticals, Inc.
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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