The short version
13 companies supply this market — deep enough that no single failure threatens the supply.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Nelarabine
Nelarabine · NELARABINE 5 mg/mL · Injection · Intravenous · Zydus Pharmaceuticals USA Inc.
NDC 70710-1726-08 · 6 VIAL, SINGLE-DOSE in 1 CARTON / 50 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.
Estimated fill cost
WAC per package, as filed
$3,966.00
Reported to Texas DSHS · 2026 annual filing · Zydus Pharmaceuticals (USA) Inc
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Medicare Part B (ASP)
Payment limit per 50 MG
$65.407
HCPCS J9261 · Jul 1, 2026 quarter · typically ASP + 6%
Medicaid spend (2025)
$124,980
60 prescriptions paid by Medicaid nationally · all Medicaid spend →
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- analysis · manufacture
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
- ANDA215037
- TE code
- AP
- Approval date
- Nov 17, 2021
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · OngoingFeb 13, 2025Zydus Pharmaceuticals (USA) Inc — Failed Impurities/Degradation Specifications
Manufacturers of Nelarabine (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Shorla Oncology Inc. | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Inc. | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Dr. Reddy's Laboratories, Inc. | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Gland Pharma Limited | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Meitheal Pharmaceuticals Inc | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Novadoz Pharmaceuticals LLC | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Novartis Pharmaceuticals Corporation | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sandoz Inc | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| XGen Pharmaceuticals DJB, Inc. | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | NELARABINE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | NELARABINE 5 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Nelarabine — NDC 70710-1726-08," retrieved September 3, 2026, https://drugdashboards.com/drug/70710172608.
Free to cite with attribution — see how the data is put together.