"60505-4858-3" National Drug Code (NDC)

Tofacitinib 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4858-3)
(Apotex Corp.)

NDC Code60505-4858-3
Package Description30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60505-4858-3)
Product NDC60505-4858
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTofacitinib
Non-Proprietary NameTofacitinib
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260603
Marketing Category NameANDA
Application NumberANDA220458
ManufacturerApotex Corp.
Substance NameTOFACITINIB CITRATE
Strength11
Strength Unitmg/1
Pharmacy ClassesJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]

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