The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Balfaxar
Prothrombin Complex Concentrate (Human) · COAGULATION FACTOR IX HUMAN 25.5 [iU]/mL; PROTHROMBIN 26 [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 · Powder, For Solution · Intravenous · Octapharma USA Inc
NDC 68982-0261-01 · 1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS · BLA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$3.15
Reported to Texas DSHS · 2026 annual filing · Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicaid spend (2025)
$19,582
29 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Is this a "specialty" drug?
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- BLA125776
- TE code
- —
- Approval date
- —
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Prothrombin Complex Concentrate (Human) (Powder, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Octapharma USA Inc | COAGULATION FACTOR IX HUMAN 25.5 [iU]/mL; PROTHROMBIN 26 [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 | Aug 26, 2026 | Sep 2, 2026 |
| Octapharma USA Inc | COAGULATION FACTOR IX HUMAN 25.5 [iU]/mL; PROTHROMBIN 16.5 [iU]/mL; COAGULATION FACTOR VII HUMAN 24 [iU]/mL; COAGULATION FACTOR X HUMAN 22 [iU]/mL; PROTEIN C 22 [iU]/mL; PROTEIN S HUMAN 26 [iU]/mL | Jul 22, 2026 | Aug 19, 2026 |
| Octapharma USA Inc | 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 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Balfaxar — NDC 68982-0261-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68982026101.
Free to cite with attribution — see how the data is put together.