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Trofinetide

Trofinetide · TROFINETIDE 50 kg/50kg · Powder · Biophore India Pharmaceuticals Pvt. Ltd

NDC 73435-0062-11 · 50 kg in 1 DRUM · BULK INGREDIENT · View full market →

Bulk ingredient — not a finished product

This NDC is a raw material (bulk ingredient) 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 $59,393.36 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 Trofinetide (Powder)

LabelerStrengthFirst seenLast seen
Biophore India Pharmaceuticals Pvt. LtdTROFINETIDE 50 kg/50kgJul 15, 2026Sep 2, 2026
Corden Pharma Bergamo SpATROFINETIDE 1 kg/kgJul 15, 2026Sep 2, 2026
F.i.s. Fabbrica Italiana Sintetici S.p.a.TROFINETIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Flamma S.p.a.TROFINETIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedTROFINETIDE 50 kg/50kgAug 7, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Trofinetide — NDC 73435-0062-11," retrieved September 3, 2026, https://drugdashboards.com/drug/73435006211.

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