DrugDashboards

Leucovorin Calcium

Leucovorin Calcium · LEUCOVORIN CALCIUM 350 mg/17.5mL · Injection, Powder, Lyophilized, For Solution · Intramuscular; Intravenous · Gland Pharma Limited

NDC 68083-0587-01 · 1 VIAL in 1 CARTON / 17.5 mL in 1 VIAL · ANDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble.

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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

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 $46.44 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA218200
TE code
AP
Approval date
Nov 12, 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 Leucovorin Calcium (Injection, Powder, Lyophilized, For Solution)

LabelerStrengthFirst seenLast seen
BluePoint LaboratoriesLEUCOVORIN CALCIUM 200 mg/20mLJul 15, 2026Sep 3, 2026
BluePoint LaboratoriesLEUCOVORIN CALCIUM 100 mg/10mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCLEUCOVORIN CALCIUM 200 mg/20mLJul 15, 2026Sep 3, 2026
Hikma Pharmaceuticals USA Inc.LEUCOVORIN CALCIUM 200 mg/20mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCLEUCOVORIN CALCIUM 500 mg/50mLJul 15, 2026Sep 2, 2026
Gland Pharma LimitedLEUCOVORIN CALCIUM 350 mg/17.5mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., UsaLEUCOVORIN CALCIUM 350 mg/17.5mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.LEUCOVORIN CALCIUM 350 mg/17.5mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.LEUCOVORIN CALCIUM 50 mg/5mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.LEUCOVORIN CALCIUM 100 mg/10mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.LEUCOVORIN CALCIUM 100 mg/10mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.LEUCOVORIN CALCIUM 500 mg/50mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.LEUCOVORIN CALCIUM 50 mg/5mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.LEUCOVORIN CALCIUM 350 mg/17.5mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.LEUCOVORIN CALCIUM 200 mg/20mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLEUCOVORIN CALCIUM 500 mg/50mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLEUCOVORIN CALCIUM 100 mg/10mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLEUCOVORIN CALCIUM 200 mg/20mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLEUCOVORIN CALCIUM 350 mg/17.5mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsLEUCOVORIN CALCIUM 50 mg/5mLJul 15, 2026Sep 2, 2026
Slate Run Pharmaceuticals, LLCLEUCOVORIN CALCIUM 100 mg/1Jul 15, 2026Sep 2, 2026
Slate Run Pharmaceuticals, LLCLEUCOVORIN CALCIUM 500 mg/1Jul 15, 2026Sep 2, 2026
Slate Run Pharmaceuticals, LLCLEUCOVORIN CALCIUM 350 mg/1Jul 15, 2026Sep 2, 2026
Slate Run Pharmaceuticals, LLCLEUCOVORIN CALCIUM 200 mg/1Jul 15, 2026Sep 2, 2026
Slate Run Pharmaceuticals, LLCLEUCOVORIN CALCIUM 50 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesLEUCOVORIN CALCIUM 350 mg/17.5mLJul 15, 2026Aug 31, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Leucovorin Calcium — NDC 68083-0587-01," retrieved September 3, 2026, https://drugdashboards.com/drug/68083058701.

Free to cite with attribution — see how the data is put together.