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Sezaby

phenobarbital sodium · PHENOBARBITAL SODIUM 100 mg/1 · Injection · Intravenous · Sun Pharmaceutical Industries, Inc.

NDC 62756-0301-01 · 1 INJECTION in 1 VIAL, SINGLE-DOSE · NDA · View full market →

The short version

5 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

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
$133.38
Reported to Texas DSHS · 2026 annual filing · Sun Pharma

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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,172.80 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA215910
TE code
Approval date
Nov 17, 2022
Patents / exclusivity
2 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityODE-414Nov 17, 2029
patent11857683Apr 7, 2042
patent12636254Apr 7, 2042

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of phenobarbital sodium (Injection)

LabelerStrengthFirst seenLast seen
Bryant Ranch PrepackPHENOBARBITAL SODIUM 130 mg/mLJul 15, 2026Sep 3, 2026
Bryant Ranch PrepackPHENOBARBITAL SODIUM 65 mg/mLJul 15, 2026Sep 3, 2026
BPI Labs LLCPHENOBARBITAL SODIUM 65 mg/mLJul 15, 2026Sep 2, 2026
BPI Labs LLCPHENOBARBITAL SODIUM 130 mg/mLJul 15, 2026Sep 2, 2026
Cameron PharmaceuticalsPHENOBARBITAL SODIUM 65 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.PHENOBARBITAL SODIUM 130 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.PHENOBARBITAL SODIUM 65 mg/mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.PHENOBARBITAL SODIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Cameron PharmaceuticalsPHENOBARBITAL SODIUM 130 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Sezaby — NDC 62756-0301-01," retrieved September 3, 2026, https://drugdashboards.com/drug/62756030101.

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