DrugDashboards

Lumacaftor/Ivacaftor Paediatric

Lumacaftor/Ivacaftor Paediatric · IVACAFTOR 125 mg/1; LUMACAFTOR 100 mg/1 · Tablet, Film Coated · Aesica Queenborough Limited

NDC 43798-0014-01 · 1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 24000 TABLET, FILM COATED 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.

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 Lumacaftor/Ivacaftor Paediatric (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Aesica Queenborough LimitedIVACAFTOR 125 mg/1; LUMACAFTOR 100 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lumacaftor/Ivacaftor Paediatric — NDC 43798-0014-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43798001401.

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