HomeNDC LookupIngredientsLeucovorin Calcium › 42806-0358-01
Leucovorin Calcium 5 mg Tablet, 100-count — NDC 42806-0358-01 package photo

Leucovorin Calcium 5 mg Tablet, 100-count

by Epic Pharma LLC · 100 TABLET in 1 BOTTLE (42806-358-01)
NDC 42806-0358-01
🏷️ FDA NDC (as labeled) 42806-358-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.3430 NADAC Per package$34.30 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.6249/unit · Part D plans $0.7402/unit — full pricing hub ↓
Also comes in: 30 tablets 42806-0358-30
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 42806-358-01
Product NDC 42806-358
11-digit billing NDC 42806035801
NCPDP billing unit EA — each (per item)
UNII RPR1R4C0P4
UPC 0342806133217, 0342806359259, 0342806134245, 0342806358016
Application # ANDA074544
SPL Set ID 2627a485-05b5-4dab-ac20-dc840e5c469d
Established class (EPC) Folate Analog
Chemical class Folic Acid
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-16
Route ORAL
Dosage form TABLET
Substance LEUCOVORIN CALCIUM
GPI-14 21755040100310
GPI class Leucovorin Calcium
GCN Seq No 044539
GCN 87558
HICL code 001063
Ingredient (HICL) Leucovorin Calcium
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1I
Therapeutic class — specific (HIC3) Chemotherapy Rescue/Antidote Agents
AHFS code 91:04.12.00
AHFS class Chemotherapy Antidotes/Protectants
FDB label name LEUCOVORIN CALCIUM 5 MG TAB
FDB brand name Leucovorin Calcium
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 42806-358-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42806-0358-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Folate Analog class.

Pharmacologic class Folate Analog
Drug family (ATC) Detoxifying agents for antineoplastic treatment
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerEpic Pharma LLC
Application holderEPIC PHARMA LLC
FDA applicationANDA074544 (ANDA)
Labeler code42806
First marketedApr 2020
Product typeHuman Prescription Drug
Portfolio27 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LEUCOVORIN CALCIUM 5 MG TAB Ingredient Leucovorin Calcium
📖 What it is MedlinePlus · NLM

Leucovorin is used to prevent harmful effects of methotrexate (a cancer chemotherapy medication) or to treat an overdose of methotrexate or similar medications. It is also used to treat people who have an inherited condition that prevents folate from reaching the brain. Leucovorin is in a class of medications called folic acid analogs. It works by protecting healthy cells from the effects of methotrexate or similar medications while allowing methotrexate to enter and kill cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on which chemo drug you're getting. If you're on methotrexate, leucovorin acts as a 'rescue' — it replenishes the folate that methotrexate blocks, protecting your health...
  • Why am I taking leucovorin alongside my chemotherapy?
  • You can take the leucovorin calcium tablet with or without food — whichever is easier on your stomach. If swallowing a whole tablet is difficult, you can crush it and mix it with f...
  • Can I take the tablet with food, or does it have to be on an empty stomach?
📖 Read our full Leucovorin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintE;359
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII R4OXA9G5BV
    A fatty acid salt derived from palm and stearic oils. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking together.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.343 $34.30 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.6249 $62.49 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.7402 $74.02 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.873 $0.302
▼ Down 53% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leucovorin Calcium 5 mg 00054-4496-13 Hikma 30 tablets $0.343 AB Availability likely
Leucovorin Calcium 5 mg 00054-8496-19 Hikma 50 tablets $0.343 AB Availability likely
Leucovorin Calcium 5 mg 00555-0484-01 Teva 30 tablets $0.343 AB Availability likely
Leucovorin Calcium 5 mgthis 42806-0358-01 Epic 100 tablets $0.343 AB Availability likely
Leucovorin Calcium 5 mg 50742-0181-01 Ingenus 100 tablets $0.343 AB Availability likely
Leucovorin Calcium 5 mg 69315-0184-01 Leading 100 tablets $0.343 AB Availability likely
Lederle Leucovorin 5 mg 00069-5886-24 Pfizer 24 tablets FDA listed
Leucovorin Calcium 5 mg 71205-0908-00 Proficient 100 tablets AB FDA listed
Lederle Leucovorin 5 mg 73591-5886-01 FARMASIERRA 100 tablets FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42806-0358-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5K
Units reimbursed last 4 qtrs
215.7K
Gross reimbursed last 4 qtrs
$134.8K
Avg / prescription
$26.70
Avg / unit
$0.6249
Latest quarter Q4 2025
2.5KRx
Medicaid pays / ea
$0.6249
gross reimbursed
vs
NADAC / ea
$0.3430
acquisition cost
=
Spread
+$0.2819
+82% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
38% FFS 62% MCO
Fee-for-service · 1,893 Rx Managed care · 3,155 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 7,738 units · 99.1 per 100k residents WA Idaho: 4,374 units · 223 per 100k residents ID Montana: 1,176 units · 104 per 100k residents MT North Dakota: no data reported ND Minnesota: 4,388 units · 76.5 per 100k residents MN Wisconsin: 4,662 units · 78.9 per 100k residents WI Michigan: 2,744 units · 27.3 per 100k residents MI New York: 8,974 units · 45.9 per 100k residents NY Vermont: no data reported VT New Hampshire: 2,092 units · 149 per 100k residents NH Oregon: 3,865 units · 91.3 per 100k residents OR Nevada: 787 units · 24.6 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,141 units · 35.6 per 100k residents IA Illinois: 1,813 units · 14.4 per 100k residents IL Indiana: 4,414 units · 64.3 per 100k residents IN Ohio: 11,002 units · 93.4 per 100k residents OH Pennsylvania: 10,696 units · 82.5 per 100k residents PA New Jersey: 1,580 units · 17.0 per 100k residents NJ Massachusetts: no data reported MA California: 32,021 units · 82.2 per 100k residents CA Utah: 833 units · 24.4 per 100k residents UT Colorado: 5,092 units · 86.6 per 100k residents CO Nebraska: 1,563 units · 79.0 per 100k residents NE Missouri: 3,626 units · 58.5 per 100k residents MO Kentucky: 4,532 units · 100 per 100k residents KY West Virginia: no data reported WV Virginia: 3,526 units · 40.5 per 100k residents VA Maryland: 1,490 units · 24.1 per 100k residents MD Connecticut: 2,150 units · 59.4 per 100k residents CT Rhode Island: no data reported RI Arizona: 5,223 units · 70.3 per 100k residents AZ New Mexico: no data reported NM Kansas: 2,337 units · 79.5 per 100k residents KS Arkansas: 1,072 units · 35.0 per 100k residents AR Tennessee: 4,738 units · 66.5 per 100k residents TN North Carolina: 6,461 units · 59.6 per 100k residents NC South Carolina: 3,483 units · 64.8 per 100k residents SC Delaware: no data reported DE Oklahoma: 8,732 units · 215 per 100k residents OK Louisiana: 4,660 units · 102 per 100k residents LA Mississippi: 612 units · 20.8 per 100k residents MS Alabama: 2,744 units · 53.7 per 100k residents AL Georgia: 4,869 units · 44.1 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 17,202 units · 56.4 per 100k residents TX Florida: 18,871 units · 83.5 per 100k residents FL
Units reimbursed · per 100k residents
14.4223
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Idaho 223 /100k
2 Oklahoma 215 /100k
3 New Hampshire 149 /100k
4 Montana 104 /100k
5 Louisiana 102 /100k
6 Kentucky 100 /100k
7 Washington 99.1 /100k
8 Ohio 93.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets42806-0358-30 5,518 Rx · $128,818
100 tablets this page42806-0358-01 5,048 Rx · $134,781
Drug total (last 4 qtrs): 10,566 Rx · 419,188 units · $263,599 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Leucovorin Calcium — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Leucovorin Calcium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.78M
Claims incl. refills
30.9K
Beneficiaries
21.1K
Spend / beneficiary
$84.30
Spend / claim
$57.57
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Leucovorin Calcium — the ingredient across all brands.

Top reported reactions

Diarrhoea1,799
Nausea1,388
Vomiting1,135
Neutropenia1,094
Pyrexia1,011
Fatigue873
Disease Progression772

Reporter sex

19,003 reports
Male · 54%
Female · 45%
Unknown · 1%

Serious outcomes

Death2,532
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,950 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
42806-0358-01 You're viewing this 100 TABLET in 1 BOTTLE (42806-358-01) $0.3430 / ea $34.30 2020-04-16 Active
42806-0358-30 30 TABLET in 1 BOTTLE (42806-358-30) $0.3430 / ea $10.29 2020-04-16 Active

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.3430 NADAC).

This pack accounts for about 48% of this product's recent Medicaid fills; most go to the 30 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 42806-0358-01?
NDC 42806-0358-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 42806-0358-01 and NDC 42806-0358-30?
Both are Leucovorin Calcium 5 mg Tablet — the drug itself is identical. NDC 42806-0358-01 is the 100-count package, while NDC 42806-0358-30 is the 30 tablets package.
What NDC number is used to bill for this package of Leucovorin Calcium 5 mg Tablet?
Bill NDC 42806-0358-01 — the 11-digit billing format is 42806035801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 28 words

INDICATIONS AND USAGE Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Leucovorin calcium tablets are intended for oral administration. Because absorption is saturable, oral administration of doses greater than 25 mg is not recommended. Impaired Methotrexate Elimination or Inadvertent Overdosage: Leucovorin rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see WARNINGS ) 2 .

Leucovorin 15 mg (10 mg/m 2 ) should be administered IM, IV, or PO every 6 hours until serum methotrexate level is less than 10 -8 M. In the presence of gastrointestinal toxicity, nausea or vomiting, leucovorin should be administered parenterally. Serum creatinine and methotrexate levels should be determined at 24-hour intervals.

If the 24 hour serum creatinine has increased 50% over baseline or if the 24 hour methotrexate level is greater than 5 x 10 -6 M or the 48 hour level is greater than 9 x 10 -7 M, the dose of leucovorin should be increased to 150 mg (100 mg/m 2 ) IV every 3 hours until the methotrexate level is less than 10 -8 M. Doses greater than 25 mg should be given parenterally (see ). Hydration (3 L/d) and urinary alkalinization with sodium bicarbonate should be employed concomitantly.

The bicarbonate dose should be adjusted to maintain the urine pH at 7 or greater. The recommended dose of leucovorin to counteract hematologic toxicity from folic acid antagonists with less affinity for mammalian dihydrofolate reductase than methotrexate (i.e., trimethoprim, pyrimethamine) is substantially less, and 5 to 15 mg of leucovorin per day has been recommended by some investigators. Patients who experience delayed early methotrexate elimination are likely to develop reversible non-oliguric renal failure.

In addition to appropriate leucovorin therapy, these patients require continuing hydration and urinary alkalinization, and close monitoring of fluid and electrolyte status, until serum methotrexate level has fallen below 0.05 micromolar and the renal failure has resolved. Some patients will have abnormalities in methotrexate elimination or renal function following methotrexate administration, which are significant but less severe. These abnormalities may or may not be associated with significant clinical toxicity.

If significant clinical toxicity is observed, leucovorin rescue should be extended for an additional 24 hours (total of 14 doses over 84 hours) in subsequent courses of therapy. The possibility that the patient is taking other medications which interact with methotrexate (e.g., medications which may interfere with methotrexate elimination or binding to serum albumin) should always be reconsidered when laboratory abnormalities or clinical toxicities are observed.

Contraindications 32 words

CONTRAINDICATIONS Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of Vitamin B 12 . A hematologic remission may occur while neurologic manifestations continue to progress.

⚠️ Warnings 178 words

WARNINGS In the treatment of accidental overdosage of folic acid antagonists, leucovorin should be administered as promptly as possible. As the time interval between antifolate administration (e.g., methotrexate) and leucovorin rescue increases, leucovorin’s effectiveness in counteracting hematologic toxicity decreases. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.

Delayed methotrexate excretion may be caused by a third space fluid accumulation (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration. Under such circumstances, higher doses of leucovorin or prolonged administration may be indicated. Doses higher than those recommended for oral use must be given intravenously.

Leucovorin may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil. 1 Concomitant granulocytopenia and fever were present in some but not all of the patients.

The concomitant use of leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo-controlled study.

🤒 Adverse Reactions 21 words

ADVERSE REACTIONS Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin.

🔄 Drug Interactions 88 words

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 children. Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate.

Leucovorin may enhance the toxicity of fluorouracil (see WARNINGS ).

🤰 Pregnancy 49 words

Pregnancy Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with leucovorin. It is also not known whether leucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Leucovorin should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 6 words

Pediatric Use See Drug Interactions subsection.

🆘 Overdosage 14 words

OVERDOSAGE Excessive amounts of leucovorin may nullify the chemotherapeutic effect of folic acid antagonists.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Leucovorin is a racemic mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)- L -isomer, known as Citrovorum factor, or (-)-folinic acid. Leucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of “one-carbon” moieties.

Following oral administration, leucovorin is rapidly absorbed and enters the general body pool of reduced folates. The increase in plasma and serum folate activity (determined microbiologically with Lactobacillus casei ) seen after oral administration of leucovorin is predominantly due to 5-methyltetrahydrofolate. Twenty normal men were given a single, oral 15 mg dose (7.5 mg/m 2 ) of leucovorin calcium and serum folate concentrations were assayed with L. casei.

Mean values observed (± one standard error) were: a) Time to peak serum folate concentration: 1.72 ± 0.08 hours, b) Peak serum folate concentration achieved: 268 ± 18 ng/mL, c) Serum folate half-disappearance time: 3.5 hours. Oral tablets yielded areas under serum folate concentration-time curves (AUCs) that were 12% greater than equal amounts of leucovorin given intramuscularly and equal to the same amounts given intravenously. Oral absorption of leucovorin is saturable at doses above 25 mg.

The apparent bioavailability of leucovorin was 97% for 25 mg, 75% for 50 mg and 37% for 100 mg.

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Leucovorin Calcium Tablets USP, 5 mg are off-white, round biconvex tablets, debossed “Є” above “ 358 ” on one side and bisected on the other side and are supplied as follows. NDC 42806-358-30 Bottles of 30 NDC 42806-358-01 Bottles of 100 Leucovorin Calcium Tablets USP, 10 mg are off-white, round biconvex tablets, debossed “Є” above “ 133 ” on one side and bisected on the other side and are supplied as follows. NDC 42806-133-21 Bottles of 12 NDC 42806-133-24 Bottles of 24 Leucovorin Calcium Tablets USP, 15 mg are off-white, round biconvex tablets, debossed “Є” above “ 134 ” on one side and bisected on the other side and are supplied as follows.

NDC 42806-134-24 Bottles of 24 Leucovorin Calcium Tablets USP, 25 mg are off-white, round biconvex tablets, debossed “Є” above “ 359 ” on one side and bisected on one side and plain on the other side and are supplied as follows. NDC 42806-359-25 Bottles of 25 Store at Controlled Room Temperature 15° to 30°C (59° to 86°F). Protect from light and moisture.

REFERENCES 1. Grem JL, Shoemaker DD, Petrelli NJ, Douglas HO. Severe and fatal toxic effects observed in treatment with high- and low-dose leucovorin plus 5-fluorouracil for colorectal carcinoma.

Cancer Treat Rep 1987; 71: 1122. 2. Link MP, Goorin AM, Miser AW et al.

The effect of adjuvant chemotherapy on relapse-free survival patients with osteosarcoma of the extremity. N Engl J Med 1986; 314:1600 – 1606. Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Rev.

06-2023-00 MF358REV06/23 OE2930

📋 Description 119 words

DESCRIPTION Leucovorin calcium tablets USP contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin as the calcium salt of N -[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]- L -glutamic acid. This is equivalent to either 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium, respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose.

Leucovorin is a water-soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium is: C 20 H 21 CaN 7 O 7 MW 511.51 leucovorin\structural.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.