elexacaftor, tezacaftor, and ivacaftor
elexacaftor, tezacaftor, and ivacaftor · TEZACAFTOR 25 mg/1; ELEXACAFTOR 50 mg/1; IVACAFTOR 37.5 mg/1 · Tablet, Film Coated · Patheon Pharmaceuticals Inc.
NDC 67651-0404-00 · 39790 TABLET, FILM COATED in 1 DRUM · 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
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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 elexacaftor, tezacaftor, and ivacaftor (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Patheon Pharmaceuticals Inc. | TEZACAFTOR 25 mg/1; ELEXACAFTOR 50 mg/1; IVACAFTOR 37.5 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Patheon Pharmaceuticals Inc. | TEZACAFTOR 50 mg/1; ELEXACAFTOR 100 mg/1; IVACAFTOR 75 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Patheon Pharmaceuticals Inc. | TEZACAFTOR 100 mg/1; ELEXACAFTOR 75 mg/1; IVACAFTOR 50 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Patheon Pharmaceuticals Inc. | TEZACAFTOR 50 mg/1; ELEXACAFTOR 37.5 mg/1; IVACAFTOR 25 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Patheon Pharmaceuticals Inc. | ELEXACAFTOR 100 mg/1; IVACAFTOR 75 mg/1; TEZACAFTOR 50 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Patheon Pharmaceuticals Inc. | ELEXACAFTOR 50 mg/1; IVACAFTOR 37.5 mg/1; TEZACAFTOR 25 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, "elexacaftor, tezacaftor, and ivacaftor — NDC 67651-0404-00," retrieved September 3, 2026, https://drugdashboards.com/drug/67651040400.
Free to cite with attribution — see how the data is put together.