"52605-068-13" National Drug Code (NDC)

Darifenacin 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13)
(POLYGEN PHARMACEUTICALS INC.)

NDC Code52605-068-13
Package Description30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52605-068-13)
Product NDC52605-068
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameDarifenacin
Non-Proprietary NameDarifenacin Hydrobromide
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20201201
Marketing Category NameANDA
Application NumberANDA211045
ManufacturerPOLYGEN PHARMACEUTICALS INC.
Substance NameDARIFENACIN HYDROBROMIDE
Strength15
Strength Unitmg/1
Pharmacy ClassesCholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]

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