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pegvaliase-pqpz

pegvaliase-pqpz · PEGVALIASE 5 mg/mL · Injection, Solution · BioMarin Pharmaceutical Inc.

NDC 68135-0060-00 · 10000 mL 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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $25,742.86 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Palynziq

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 pegvaliase-pqpz (Injection, Solution)

LabelerStrengthFirst seenLast seen
BioMarin Pharmaceutical Inc.PEGVALIASE 20 mg/mLJul 15, 2026Sep 3, 2026
BioMarin Pharmaceutical Inc.PEGVALIASE 10 mg/.5mLJul 15, 2026Sep 2, 2026
BioMarin Pharmaceutical Inc.PEGVALIASE 2.5 mg/.5mLJul 15, 2026Sep 2, 2026
BioMarin Pharmaceutical Inc.PEGVALIASE 5 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "pegvaliase-pqpz — NDC 68135-0060-00," retrieved September 3, 2026, https://drugdashboards.com/drug/68135006000.

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