Prescription medicine
Leucovorin Brand names: Vykoura
Leucovorin (Vykoura) is a prescription medicine with an FDA approval on record since 1952. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.330 per leucovorin calcium 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the leucovorin FDA label on DailyMed (effective March 19, 2025, Meitheal Pharmaceuticals Inc.); the NDA 8107 record on Drugs@FDA; every leucovorin label on DailyMed.
Highlights of the record
FDA label of March 19, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLeucovorin Calcium for Injection rescue is indicated after high dose methotrexate therapy in osteosarcoma.
Forms and strengths
- 5 mg
- 10 mg
- 15 mg
- 25 mg
- 50 mg
- 100 mg
- 200 mg
- 350 mg
- 500 mg
- 10 mg/ml
- 50 mg/5ml
- 100 mg/10ml
Injection (powder) (lyophilized) for solution; tablet; injection; injection (powder) (lyophilized) for suspension.
On the market
- Earliest approval on file
- June 20, 1952 Leucovorin Calcium, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 42 first January 2, 1987; 24 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 23, 2044 Vykoura injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.330 per tablet Leucovorin calcium 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2012 0 Class I among all firms' recalls; latest July 29, 2021; 5 more by firms not listed as its makers
- FAERS reports
- 19,004 through July 30, 2026
What is leucovorin used for?
From the label: indications and usageLeucovorin Calcium for Injection rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin Calcium for Injection is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin Calcium for Injection is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin Calcium for Injection is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. […]
Conditions named in the indications of leucovorin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Folate Analog.
Source: FDA drug label (leucovorin calcium), Meitheal Pharmaceuticals Inc., effective March 19, 2025 (SPL set 9df20901-6980-4d4e-89ec-40f3c1f91852), via openFDA; the full label on DailyMed
Is there a generic for leucovorin (Vykoura)?
The FDA approved the first generic leucovorin on January 2, 1987. 42 generic applications are approved; 24 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists leucovorin from 16 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Leucovorin Calcium injection; a patent listed only for Vykoura injection runs to December 23, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1952 earliest approval on file
- 1987 first generic approved
- 2044 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for leucovorin (Vykoura)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.330 per Leucovorin calcium 5 mg tablet, down 20% from $0.415 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Leucovorin calcium 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Leucovorin calcium 10 mg tablet | Generic | $2.08 per tablet | $62.33 | -30% |
| Leucovorin calcium 15 mg tablet | Generic | $1.59 per tablet | $47.60 | -27% |
| Leucovorin calcium 25 mg tablet | Generic | $1.60 per tablet | $48.14 | -21% |
| Leucovorin calcium 5 mg tablet | Generic | $0.330 per tablet | $9.90 | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has leucovorin been recalled?
The FDA's Enforcement Report lists 14 recalls naming leucovorin since 2012: 0 Class I (the most serious), 13 Class II, 1 Class III; 0 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of leucovorin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| April 26, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| February 10, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility … |
| July 22, 2020 | Class III | West-Ward Columbus Inc | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. |
| October 9, 2019 | Class II | Ingenus Pharmaceuticals Llc | Crystallization: Presence of particulate matter identified as API crystallization |
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
| April 23, 2015 | Class II | South Coast Specialty Compounding, Inc. not a listed maker | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the leucovorin label say about other medicines?
The leucovorin label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name leucovorin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Glucarpidase | drug interactions | Glucarpidase can decrease leucovorin concentrations, which may decrease the effect of leucovorin rescue. |
| Levoleucovorin | contraindications | CONTRAINDICATIONS VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid [see Warnings and Precautions (5.1) ]. |
| Methotrexate | drug interactions | Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin calcium enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1-3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. |
| Phenobarbital | drug interactions | Drug Interactions Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients. |
| Phenytoin | drug interactions | Drug Interactions Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients. |
| Primidone | drug interactions | Drug Interactions Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients. |
Other labels that name leucovorin
Source: FDA drug label (leucovorin calcium), Meitheal Pharmaceuticals Inc., effective March 19, 2025 (SPL set 9df20901-6980-4d4e-89ec-40f3c1f91852), via openFDA; the full label on DailyMed
What do FAERS reports show for leucovorin?
The FDA Adverse Event Reporting System holds 19,004 reports that list leucovorin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,533 are coded as a death and 9,242 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,956, against a median of 498 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other folate analogs
- the pharmacologic class, with prices and generics
- Leucovorin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other