DrugDashboards

Extended Phenytoin Sodium

Phenytoin Sodium · PHENYTOIN SODIUM 100 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC

NDC 65162-0212-50 · 500 CAPSULE in 1 BOTTLE · ANDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. The price has jumped 58% in a year, to $0.1572 per unit — sharp rises like this often mean supply is already tightening. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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.

  • Pharmacies pay (NADAC)$0.1572per EAinvoice-surveyed acquisition cost · Apr 23, 2025
  • Part D plans paid (avg)$0.7189per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.4438per CAPweighted avg manufacturer price $0.2536 · May 1, 2025282% of what pharmacies pay — higher than 90% of drugs with this benchmark

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

$0$0.25$0.5$0.75Nov 2013Apr 2025$0.1572
139 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$4.71
#90 count
$14.14

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$1,282
53 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for phenytoin sodium (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 →

Where it's made

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

Regulatory

Application
ANDA040765
TE code
AB
Approval date
Nov 12, 2008
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedOct 27, 2023
    Amneal Pharmaceuticals of New York, LLCFailed Dissolution Specifications
  • Class II · TerminatedMay 30, 2023
    Amneal Pharmaceuticals of New York, LLCFailed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
  • Class II · TerminatedAug 17, 2013
    Amneal Pharmaceuticals of New York, LLC.Failed dissolution specifications; 18 month CRT

Manufacturers of Phenytoin Sodium (Capsule)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 3, 2026
American Health PackagingPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Direct RxPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
NCS HealthCare of KY, LLC dba Vangard LabsPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.PHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Extended Phenytoin Sodium — NDC 65162-0212-50," retrieved September 3, 2026, https://drugdashboards.com/drug/65162021250.

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