"0054-0248-12" National Drug Code (NDC)

Imatinib Mesylate 3 BLISTER PACK in 1 CARTON (0054-0248-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
(Hikma Pharmaceuticals USA Inc.)

NDC Code0054-0248-12
Package Description3 BLISTER PACK in 1 CARTON (0054-0248-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product NDC0054-0248
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameImatinib Mesylate
Non-Proprietary NameImatinib Mesylate
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20180928
Marketing Category NameANDA
Application NumberANDA207586
ManufacturerHikma Pharmaceuticals USA Inc.
Substance NameIMATINIB MESYLATE
Strength100
Strength Unitmg/1
Pharmacy ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]

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