DrugDashboards

Rufinamide

Rufinamide · RUFINAMIDE 40 mg/mL · Suspension · Oral · American Health Packaging

NDC 60687-0824-08 · 3 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply.

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 00054-0528-63) — 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
$1.01per unit
middle half $0.5629$1.95 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $1.01
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 69% · step therapy 3% · qty limit 57%

*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.

Estimated fill cost

WAC per package, as filed
$442.58
Reported to Texas DSHS · 2026 annual filing · American Health Packaging

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Supply fragility

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

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for rufinamide (other) in the next 90 days

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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

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 $1,243.89 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA207363
TE code
AB
Approval date
Apr 23, 2019
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 (Suspension)

LabelerStrengthFirst seenLast seen
American Health PackagingRUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCRUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedRUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Bionpharma Inc.RUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.RUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Eisai Inc.RUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.RUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Lupin Pharmaceuticals, Inc.RUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
NorthStar RxLLCRUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCRUFINAMIDE 40 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Rufinamide — NDC 60687-0824-08," retrieved September 3, 2026, https://drugdashboards.com/drug/60687082408.

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