Ivacaftor
Ivacaftor · IVACAFTOR 1 kg/kg · Powder · Zhejiang Ausun Pharmaceutical Co., Ltd.
NDC 76397-0061-05 · 10 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 $26,092.63 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 Ivacaftor (Powder)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alivus Life Sciences Limited | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | IVACAFTOR 50 kg/50kg | Jul 15, 2026 | Sep 2, 2026 |
| Biocon Limited | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| Hetero Labs Limited | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| Maithri Drugs Private Limited | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| Medichem Manufacturing (Malta) Ltd. | IVACAFTOR 75 kg/75kg | Jul 15, 2026 | Sep 2, 2026 |
| Medichem S.A. | IVACAFTOR 75 kg/75kg | Jul 15, 2026 | Sep 2, 2026 |
| MSN Laboratories Private Limited | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| ScinoPharm Taiwan Ltd. | IVACAFTOR 7.5 kg/7.5kg | Jul 15, 2026 | Sep 2, 2026 |
| Shanghai SynTheAll Pharmaceutical Co., Ltd. | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| Viyash Life Sciences Private Limited | IVACAFTOR 1 kg/kg | Jul 15, 2026 | Sep 2, 2026 |
| Zhejiang Ausun Pharmaceutical Co., Ltd. | IVACAFTOR 1 kg/kg | Aug 19, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Ivacaftor — NDC 76397-0061-05," retrieved September 3, 2026, https://drugdashboards.com/drug/76397006105.
Free to cite with attribution — see how the data is put together.