The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Zanubrutinib
Zanubrutinib · ZANUBRUTINIB 80 mg/1 · Capsule, Gelatin Coated · Catalent Pharma Solutions, LLC
NDC 11014-0472-01 · 12 BOTTLE in 1 BOX / 120 CAPSULE, GELATIN COATED in 1 BOTTLE · EXPORT ONLY · View full market →
Medicare Part D
This product is labeled for export only and is not sold to US patients, so Medicare does not price 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 11014-0472-01," retrieved September 3, 2026, https://drugdashboards.com/drug/11014047201.
Free to cite with attribution — see how the data is put together.