DrugDashboards

Banzel

rufinamide · RUFINAMIDE 400 mg/1 · Tablet, Film Coated · Oral · Pharma Packaging Solutions, LLC dba Tjoapack LLC

NDC 75929-0098-12 · 120 TABLET, FILM COATED in 1 BOTTLE · NDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00054-0426-23) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$5.05per unit
middle half $2.75$6.21 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$3.03–$3.78
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 69% · step therapy 3% · qty limit 58%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

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 $4,785.61 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA021911
TE code
AB
Approval date
Nov 14, 2008
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 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, "Banzel — NDC 75929-0098-12," retrieved September 3, 2026, https://drugdashboards.com/drug/75929009812.

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