"0574-1811-30" National Drug Code (NDC)

Tofacitinib Citrate 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0574-1811-30)
(Padagis US LLC)

NDC Code0574-1811-30
Package Description30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0574-1811-30)
Product NDC0574-1811
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTofacitinib Citrate
Non-Proprietary NameTofacitinib Citrate
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260615
Marketing Category NameANDA
Application NumberANDA216001
ManufacturerPadagis US LLC
Substance NameTOFACITINIB CITRATE
Strength11
Strength Unitmg/1
Pharmacy ClassesJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]

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