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Rufinamide

Rufinamide · RUFINAMIDE 100 mg/1 · Tablet, Film Coated · Bushu Pharmaceuticals, Ltd.

NDC 51148-0008-01 · 1 BAG in 1 DRUM / 80000 TABLET, FILM COATED in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for rufinamide (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,715.07 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Rufinamide (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedRUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedRUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Bushu Pharmaceuticals, Ltd.RUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Bushu Pharmaceuticals, Ltd.RUFINAMIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Bushu Pharmaceuticals, Ltd.RUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.RUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.RUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Eisai Inc.RUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Eisai Inc.RUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USARUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USARUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.RUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.RUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.RUFINAMIDE 400 mg/1Jul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.RUFINAMIDE 200 mg/1Jul 15, 2026Sep 2, 2026
Pharma Packaging Solutions, LLC dba Tjoapack LLCRUFINAMIDE 400 mg/1Jul 15, 2026Jul 22, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Rufinamide — NDC 51148-0008-01," retrieved September 3, 2026, https://drugdashboards.com/drug/51148000801.

Free to cite with attribution — see how the data is put together.