"0054-0821-58" National Drug Code (NDC)

Tofacitinib Solution 1 BOTTLE in 1 CARTON (0054-0821-58) / 240 mL in 1 BOTTLE
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0821-58
Package Description1 BOTTLE in 1 CARTON (0054-0821-58) / 240 mL in 1 BOTTLE
Product NDC0054-0821
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTofacitinib Solution
Non-Proprietary NameTofacitinib
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20260603
Marketing Category NameANDA
Application NumberANDA216878
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameTOFACITINIB CITRATE
Strength1
Strength Unitmg/mL
Pharmacy ClassesJanus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA]

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