DrugDashboards

phenytoin sodium

phenytoin sodium · PHENYTOIN SODIUM 200 mg/1 · Capsule, Extended Release · Oral · Sun Pharmaceutical Industries, Inc.

NDC 62756-0299-08 · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Sun Pharmaceutical Industries Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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 62756-0299-83) — 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
$0.9625per unit
middle half $0.6777$1.11 · 5,657 plans · Oct 1, 2024
Est. net of rebates
≈ $0.9625
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
of plans cover it

*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 4 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 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
ANDA040731
TE code
Approval date
Jun 30, 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 phenytoin sodium (Capsule, Extended Release)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 3, 2026
AvPAKPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.PHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.PHENYTOIN SODIUM 300 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPPHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.PHENYTOIN SODIUM 300 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.PHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.PHENYTOIN SODIUM 200 mg/1Jul 15, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.PHENYTOIN SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.PHENYTOIN SODIUM 100 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "phenytoin sodium — NDC 62756-0299-08," retrieved September 3, 2026, https://drugdashboards.com/drug/62756029908.

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