"70377-057-11" National Drug Code (NDC)

Tofacitinib 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11)
(Biocon Pharma Inc)

NDC Code70377-057-11
Package Description30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70377-057-11)
Product NDC70377-057
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTofacitinib
Proprietary Name SuffixXr
Non-Proprietary NameTofacitinib
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20260603
Marketing Category NameANDA
Application NumberANDA219442
ManufacturerBiocon Pharma Inc
Substance NameTOFACITINIB CITRATE
Strength11
Strength Unitmg/1
Pharmacy ClassesJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]

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