DrugDashboards

Fosphenytoin

Fosphenytoin Sodium · FOSPHENYTOIN SODIUM 50 mg/mL · Injection, Solution · Intramuscular; Intravenous · Fresenius Kabi USA, LLC

NDC 63323-0403-02 · 25 VIAL in 1 TRAY / 2 mL in 1 VIAL · ANDA · View full market →

The short version

6 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.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

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

  • Part D plans paid (avg)$12.40per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$101.45per package of 25X2MLFresenius Kabi, LLC · May 15, 2025

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
$136.75
Reported to Texas DSHS · 2026 annual filing · Fresenius Kabi USA

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

Supply fragility

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

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 $418.01 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA078052
TE code
AP
Approval date
Aug 6, 2007
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMay 2, 2014
    Fresenius Kabi USA, LLCPresence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
  • Class II · TerminatedMay 2, 2014
    Fresenius Kabi USA, LLCPresence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Manufacturers of Fosphenytoin Sodium (Injection, Solution)

LabelerStrengthFirst seenLast seen
Gland Pharma LimitedFOSPHENYTOIN SODIUM 50 mg/mLJul 15, 2026Sep 3, 2026
Pfizer Laboratories Div Pfizer IncFOSPHENYTOIN SODIUM 50 mg/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCFOSPHENYTOIN SODIUM 50 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsFOSPHENYTOIN SODIUM 50 mg/mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., UsaFOSPHENYTOIN SODIUM 50 mg/mLJul 15, 2026Aug 31, 2026
West-Ward Pharmaceuticals CorpFOSPHENYTOIN SODIUM 50 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Fosphenytoin — NDC 63323-0403-02," retrieved September 3, 2026, https://drugdashboards.com/drug/63323040302.

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