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.
Levoleucovorin Calcium
levoleucovorin injection · LEVOLEUCOVORIN CALCIUM 10 mg/1 · Injection, Solution · Intravenous · Hainan Poly Pharm. Co., Ltd.
NDC 14335-0341-01 · 1 VIAL in 1 CARTON / 25 INJECTION, SOLUTION in 1 VIAL · 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.
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 · avg $296.72 per prescription
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- ANDA217314
- TE code
- AP
- Approval date
- May 22, 2023
- 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 levoleucovorin injection (Injection, Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hainan Poly Pharm. Co., Ltd. | LEVOLEUCOVORIN CALCIUM 10 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Hainan Poly Pharm. Co., Ltd. | LEVOLEUCOVORIN CALCIUM 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Slate Run Pharmaceuticals | LEVOLEUCOVORIN CALCIUM 10 mg/mL | Jul 15, 2026 | Aug 29, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Levoleucovorin Calcium — NDC 14335-0341-01," retrieved September 3, 2026, https://drugdashboards.com/drug/14335034101.
Free to cite with attribution — see how the data is put together.