Zanubrutinib
Zanubrutinib · ZANUBRUTINIB 80 mg/1 · Capsule, Gelatin Coated · Catalent Pharma Solutions, LLC
NDC 11014-0395-02 · 1 BAG in 1 DRUM / 76389 CAPSULE, GELATIN 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.
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 $13,186.84 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 Zanubrutinib (Capsule, Gelatin Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Catalent Pharma Solutions, LLC | ZANUBRUTINIB 80 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Zanubrutinib — NDC 11014-0395-02," retrieved September 3, 2026, https://drugdashboards.com/drug/11014039502.
Free to cite with attribution — see how the data is put together.