Lumacaftor and Ivacaftor
Lumacaftor and Ivacaftor · LUMACAFTOR 200 mg/1; IVACAFTOR 125 mg/1 · Tablet, Film Coated · Aesica Queenborough Limited
NDC 43798-0004-01 · 1 POUCH in 1 DRUM / 1 BAG in 1 POUCH / 17700 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
All Part D pricing →Matched to CMS's representative package for this drug (NDC 51167-0809-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
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
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- TE code
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- Approval date
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- Patents / exclusivity
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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 and Ivacaftor (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aesica Queenborough Limited | LUMACAFTOR 200 mg/1; IVACAFTOR 125 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Vertex Pharmaceuticals Incorporated | LUMACAFTOR 200 mg/1; IVACAFTOR 125 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Vertex Pharmaceuticals Incorporated | LUMACAFTOR 100 mg/1; IVACAFTOR 125 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aesica Queenborough Limited | LUMACAFTOR 125 mg/1; IVACAFTOR 200 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Vertex Pharmaceuticals Incorporated | LUMACAFTOR 125 mg/1; IVACAFTOR 100 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Vertex Pharmaceuticals Incorporated | LUMACAFTOR 125 mg/1; IVACAFTOR 200 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Aesica Queenborough Limited | IVACAFTOR 125 mg/1; LUMACAFTOR 200 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Vertex Pharmaceuticals Incorporated | IVACAFTOR 125 mg/1; LUMACAFTOR 200 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Vertex Pharmaceuticals Incorporated | IVACAFTOR 125 mg/1; LUMACAFTOR 100 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Lumacaftor and Ivacaftor — NDC 43798-0004-01," retrieved September 3, 2026, https://drugdashboards.com/drug/43798000401.
Free to cite with attribution — see how the data is put together.