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"67877-890-88" National Drug Code (NDC)

Mirabegron 1 POUCH in 1 CARTON (67877-890-88) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE
(Ascend Laboratories, LLC)

NDC Code67877-890-88
Package Description1 POUCH in 1 CARTON (67877-890-88) / 1 BOTTLE in 1 POUCH / 100 mL in 1 BOTTLE
Product NDC67877-890
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameMirabegron
Non-Proprietary NameMirabegron
Dosage FormFOR SUSPENSION, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260515
Marketing Category NameANDA
Application NumberANDA219323
ManufacturerAscend Laboratories, LLC
Substance NameMIRABEGRON
Strength8
Strength Unitmg/mL
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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