DrugDashboards

Berotralstat hydrochloride

Berotralstat hydrochloride · BEROTRALSTAT 150 mg/1 · Capsule · Catalent Pharma Solutions, LLC

NDC 11014-0437-02 · 1 BAG in 1 DRUM / 22556 CAPSULE in 1 BAG · DRUG FOR FURTHER PROCESSING · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (drug for further processing) sold to drug manufacturers or compounders, not a product pharmacies dispense. Retail pricing, TE codes, fragility scores, and shortage reports don't apply to bulk listings — those attach to finished products made from this ingredient.

Medicare Part D

This is a bulk ingredient, not a dispensable product — it is a raw material sold to manufacturers and compounders, so no plan prices it.

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.

Supply fragility

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

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 $42,449.43 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
TE code
Approval date
Patents / exclusivity

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Berotralstat hydrochloride (Capsule)

LabelerStrengthFirst seenLast seen
BioCryst Pharmaceuticals, Inc.BEROTRALSTAT HYDROCHLORIDE 110 mg/1Jul 15, 2026Sep 2, 2026
BioCryst Pharmaceuticals, Inc.BEROTRALSTAT HYDROCHLORIDE 150 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCBEROTRALSTAT 150 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCBEROTRALSTAT HYDROCHLORIDE 110 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Berotralstat hydrochloride — NDC 11014-0437-02," retrieved September 3, 2026, https://drugdashboards.com/drug/11014043702.

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