# Balfaxar

NDC: 68982-261
Generic name: Prothrombin Complex Concentrate (Human)
Labeler / Manufacturer: Octapharma USA Inc
Product type: PLASMA DERIVATIVE
Marketing category: Biologic License Application
Dosage form: POWDER, FOR SOLUTION
Routes: INTRAVENOUS
Marketing started: 20231130

FDA application: BLA125776

## Active ingredients

- COAGULATION 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

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"68982-261"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=68982-261