The short version
Just 3 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.
Fludarabine Phosphate
Fludarabine Phosphate · FLUDARABINE PHOSPHATE 25 mg/mL · Injection, Solution · Intravenous · Hisun Pharmaceuticals USA, Inc.
NDC 42658-0024-01 · 1 VIAL, SINGLE-DOSE in 1 CARTON / 2 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.
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
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA220196
- TE code
- —
- Approval date
- Jul 23, 2026
- 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 Fludarabine Phosphate (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hisun Pharmaceuticals USA, Inc. | FLUDARABINE PHOSPHATE 25 mg/mL | Sep 3, 2026 | Sep 3, 2026 |
| Fresenius Kabi USA, LLC | FLUDARABINE PHOSPHATE 25 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sagent Pharmaceuticals | FLUDARABINE PHOSPHATE 25 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Fludarabine Phosphate — NDC 42658-0024-01," retrieved September 3, 2026, https://drugdashboards.com/drug/42658002401.
Free to cite with attribution — see how the data is put together.