"68982-261-01" National Drug Code (NDC)

NDC Code	68982-261-01
Package Description	1 VIAL, GLASS in 1 CARTON (68982-261-01) / 20 mL in 1 VIAL, GLASS (68982-261-81)
Product NDC	68982-261
Product Type Name	PLASMA DERIVATIVE
Proprietary Name	Balfaxar
Non-Proprietary Name	Prothrombin Complex Concentrate (human)
Dosage Form	POWDER, FOR SOLUTION
Usage	INTRAVENOUS
Start Marketing Date	20231130
Marketing Category Name	BLA
Application Number	BLA125776
Manufacturer	Octapharma USA Inc
Substance Name	COAGULATION FACTOR IX HUMAN; COAGULATION FACTOR VII HUMAN; COAGULATION FACTOR X HUMAN; PROTEIN C; PROTEIN S HUMAN; PROTHROMBIN
Strength	25.5; 16.5; 24; 22; 22; 26
Strength Unit	[iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL; [iU]/mL
Pharmacy Classes	Anti-coagulant [EPC], Blood Coagulation Factor [EPC], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Decreased Coagulation Factor Activity [PE], Enzyme Precursors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Increased Coagulation Activity [PE], Protein C [CS]