Quick answers
- What is Leucovorin calcium used for?
- The FDA-approved label (Vykoura, Avyxa Pharma, LLC, March 12, 2026) says: “VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 Reducing the toxicity of: Methotrexate in adult and pediatric patients with impaired methotrexate elimination or Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Leucovorin calcium have a boxed warning?
- No. None of the 24 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Leucovorin calcium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Leucovorin calcium been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 22, 2020 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Leucovorin calcium?
- 17 companies list prescription products of Leucovorin calcium in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., BluePoint Laboratories and Meitheal Pharmaceuticals Inc..
What Leucovorin calcium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VYKOURA is indicated for: 1.1 Rescue after high-dose methotrexate (MTX) therapy in adult and pediatric patients. 1.2 Reducing the toxicity of: Methotrexate in adult and pediatric patients with impaired methotrexate elimination or Folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients. …
— FDA label: Vykoura, Avyxa Pharma, LLC, effective March 12, 2026. Read the full label on DailyMed →
The FDA has 24 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 24 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Tablet · Injection · Injection, powder, lyophilized, for suspension |
|---|---|
| Route | Intramuscular · Intravenous · Oral |
| Prescription products | 60 in the FDA NDC Directory |
| Brand names | Vykoura |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| leucovorin calcium 10 mg tablet | Generic | $2.16 per tablet |
| leucovorin calcium 15 mg tablet | Generic | $1.59 per tablet |
| leucovorin calcium 25 mg tablet | Generic | $1.67 per tablet |
| leucovorin calcium 5 mg tablet | Generic | $0.3336 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.10 products
- BluePoint Laboratories6 products
- Meitheal Pharmaceuticals Inc.5 products
- Fresenius Kabi USA, LLC5 products
- Sagent Pharmaceuticals5 products
- Slate Run Pharmaceuticals, LLC5 products
- Ingenus Pharmaceuticals, LLC4 products
- Leading Pharma, LLC4 products
- Epic Pharma, LLC4 products
- Mylan Institutional LLC3 products
- Avyxa Pharma, LLC3 products
- Teva Pharmaceuticals USA, Inc.2 products
- Gland Pharma Limited2 products
- Proficient Rx LP1 product
- American Health Packaging1 product
- Major Pharmaceuticals1 product
- Glenmark Pharmaceuticals Inc., USA1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA220406 VYKOURA | Avyxa Holdings | February 3, 2026 | — |
Generic approvals (24)
- ANDA089384Hikma · September 14, 1987
- ANDA071198Barr · September 24, 1987
- ANDA071199Barr · September 24, 1987
- ANDA089717Hikma · March 28, 1988
- ANDA072733Hikma · February 22, 1993
- ANDA072734Hikma · February 22, 1993
- ANDA072735Hikma · February 22, 1993
- ANDA072736Hikma · February 22, 1993
- ANDA040056Hikma · May 23, 1995
- ANDA074544Epic Pharma LLC · August 28, 1997
- ANDA040258Fresenius Kabi USA · February 26, 1999
- ANDA040286Fresenius Kabi USA · February 26, 1999
- ANDA040335Hikma · April 20, 2000
- ANDA200753Sagent Pharms · September 6, 2012
- ANDA200855Sagent Pharms · September 6, 2012
- ANDA203800Mylan Labs Ltd · May 19, 2017
- ANDA209110Sagent Pharms Inc · October 26, 2017
- ANDA207241Fresenius Kabi USA · March 14, 2018
- ANDA207226Fresenius Kabi USA · July 27, 2018
- ANDA211132Ingenus Pharms LLC · July 30, 2020
- ANDA213929Leading · October 22, 2020
- ANDA217021Hainan Poly · July 10, 2023
- ANDA216590Meitheal · July 19, 2023
- ANDA218200Gland · November 12, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 22, 2020 · Class III · Terminated · D-1490-2020
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10 — West-Ward Columbus Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vykoura, Avyxa Pharma, LLC, effective March 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →