The short version
Just 2 companies supply this market — thin enough that a single exit would be felt immediately.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Paclitaxel protein-bound particles
Paclitaxel protein-bound particles · PACLITAXEL 100 mg/20mL · Injection, Powder, Lyophilized, For Suspension · Intravenous · Cipla USA Inc.
NDC 69097-0398-78 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
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.
Medicare Part B (ASP)
Payment limit per 1 MG
$6.586
HCPCS J9264 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$413,553
286 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Cipla LimitedIndiamanufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA209657
- TE code
- AB
- Approval date
- Apr 10, 2025
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Paclitaxel protein-bound particles (Injection, Powder, Lyophilized, For Suspension)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Cipla USA Inc. | PACLITAXEL 100 mg/20mL | Jul 15, 2026 | Sep 2, 2026 |
| Exelan Pharmaceuticals Inc. | PACLITAXEL 100 mg/20mL | Aug 12, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Paclitaxel protein-bound particles — NDC 69097-0398-78," retrieved September 3, 2026, https://drugdashboards.com/drug/69097039878.
Free to cite with attribution — see how the data is put together.