FDA NDC Directory · JSON-LD · Markdown

Balfaxar

NDC 68982-261 · PLASMA DERIVATIVE · POWDER, FOR SOLUTION

Generic nameProthrombin Complex Concentrate (Human)
Labeler / ManufacturerOctapharma USA Inc
Marketing categoryBiologic License Application · App BLA125776
Dosage form / routePOWDER, FOR SOLUTION · INTRAVENOUS
Active ingredientsCOAGULATION FACTOR IX HUMAN (25.5 [iU]/mL)
COAGULATION FACTOR VII HUMAN (16.5 [iU]/mL)
COAGULATION FACTOR X HUMAN (24 [iU]/mL)
PROTEIN C (22 [iU]/mL)
PROTEIN S HUMAN (22 [iU]/mL)
PROTHROMBIN (26 [iU]/mL)
Marketing started20231130
Package count2

External sources

Source: openFDA. Public-domain (CC0).