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fomepizole 1 g/mL Injection, Solution, 1 vial — NDC 00517-0710-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

fomepizole 1 g/mL Injection, Solution, 1 vial — NDC 0517-0710-01 (Billing 00517-0710-01)

by American Regent, Inc. · 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL

This is a package of 1 vial of fomepizole 1 g/mL Injection, Solution from American Regent, Inc., marketed since Jul 2018 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00517-0710-01
🏷️ FDA NDC (as labeled) 0517-0710-01 billing pads the labeler segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Main listing for product 0517-0710 · Also comes in: 1.5 mL 0517-0710-88
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0517-0710-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0517 labeler · 0710 product · 01 package
Package marketed since
Jul 16, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0300000000001
FDA record last changed
Oct 2, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0517-0710-01
Product NDC 0517-0710
11-digit billing NDC 00517071001
NCPDP billing unit ML — per mL (volume)
RxCUI 310414
UNII 83LCM6L2BY
UPC 0300000000001
Application # ANDA078368
SPL Set ID a31d0148-2729-49de-b666-f24b0dfd2401
Established class (EPC) Antidote
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-16
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FOMEPIZOLE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 93000045002010
GPI class Fomepizole
GCN Seq No 037000
GCN 07565
HICL code 016908
Ingredient (HICL) Fomepizole
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C8
Therapeutic class — intermediate (HIC2) Antidotes To Poisons
HIC3 code C8E
Therapeutic class — specific (HIC3) Antidotes,Miscellaneous
AHFS code 91:04.08.00
AHFS class Methanol Or Ethylene Glycol Poisoning
FDB label name FOMEPIZOLE 1.5 GM/1.5 ML VIAL
FDB brand name Fomepizole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 037000
  • GCN: 07565
  • GPI-14 (Medi-Span): 93000045002010
  • HICL (First Databank): 016908
  • AHFS class code: 91:04.08.00
  • RxCUI (RxNorm): 310414
Why two NDCs? The FDA registers this code as 0517-0710-01 — a 4-4-2 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 labeler segment → 00517-0710-01. 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 Antidote class.

Pharmacologic class Antidote
Drug family (ATC) Antidotes
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.

Clinical

Label name FOMEPIZOLE 1.5 GM/1.5 ML VIAL Ingredient Fomepizole
📗 Our plain-language guide HelloPharmacist
  • It's an antidote for antifreeze (ethylene glycol) or methanol poisoning, including when someone is only suspected of swallowing them. It stops the body from turning these into the...
  • It's given through an IV by healthcare staff, usually in a hospital. Each dose is diluted and given slowly over about 30 minutes, with repeat doses over time. Your team decides the...
  • Headache, nausea, dizziness, drowsiness and a metallic taste are the most common. Tell your nurse or doctor about a rash, vision changes, seizures, a very fast or slow heartbeat, o...
  • No. Alcohol and fomepizole slow each other's clearance from the body. Ask your care team about any other medicines you take as well.
📖 Read our full Fomepizole guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1451 No ASP payment limit on file for J1451 this quarter.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1.5 mL
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.

Billing & reimbursement

FDA NDC (as labeled)0517-0710-01
11-digit billing NDC00517-0710-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1451
DescriptorINJECTION, FOMEPIZOLE, 15 MG
Billing units / pkg66.67 units
How the units are derivedThis package is 1.5 ML; the HCPCS unit is 15 MG, so one package = 66.67 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00517-0710-88 0517-0710-88 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL 2020-07-31 — Active
00517-0710-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL 2018-07-16 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 vial — 1 vial in 1 carton / 1.5 ml in 1 vial.
How does this package differ from NDC 00517-0710-88?
Both are fomepizole 1 g/mL Injection, Solution — the drug itself is identical. This page's package is the 1 vial one, while NDC 00517-0710-88 is the 1 vial package.
What NDC number is used to bill for this package of fomepizole 1 g/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
fomepizole 1 g/mLthis 00517-0710-01 American 1 vial — AP FDA listed —
Fomepizole 1.5 g/1.5mL 25021-0829-02 Sagent 1 vial — AP FDA listed —
Fomepizole 1 g/mL 67457-0211-02 Mylan 1 vial — AP FDA listed —
Fomepizole 1 g/mL 68083-0510-01 Gland 1 vial — AP FDA listed —
Fomepizole 1 g/mL 68475-0510-01 Navinta 1 vial — AP FDA listed —
Fomepizole 1 g/mL 70710-1478-01 Zydus 1 vial — AP 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

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.

🧪 Avoiding an ingredient? See Fomepizole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerAmerican Regent, Inc.
Application holderAMERICAN REGENT INC
FDA applicationANDA078368 (ANDA)
Labeler code00517
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio72 products on file

More NDCs from American Regent, Inc. labeler code 00517

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 41 words ▾

INDICATIONS AND USAGE Fomepizole injection is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see DOSAGE AND ADMINISTRATION ).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) when diluting or administering fomepizole injection. Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate. Treatment Guidelines: If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication).

These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death. The diagnosis of these poisonings may be difficult because ethylene glycol and methanol concentrations diminish in the blood as they are metabolized to their respective metabolites. Hence, both ethylene glycol and methanol concentrations and acid base balance, as determined by serum electrolyte (anion gap) and/or arterial blood gas analysis, should be frequently monitored and used to guide treatment.

Treatment consists of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as fomepizole injection, and correction of metabolic abnormalities. In patients with high ethylene glycol or methanol concentrations (≥ 50 mg/dL), significant metabolic acidosis, or renal failure, hemodialysis should be considered to remove ethylene glycol or methanol and the respective toxic metabolites of these alcohols. Treatment with Fomepizole Injection : Begin fomepizole injection treatment immediately upon suspicion of ethylene glycol or methanol ingestion based on patient history and/or anion gap metabolic acidosis, increased osmolar gap, visual disturbances, or oxalate crystals in the urine, OR a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL.

Hemodialysis : Hemodialysis should be considered in addition to fomepizole injection in the case of renal failure, significant or worsening metabolic acidosis, or a measured ethylene glycol or methanol concentration of greater than or equal to 50 mg/dL. Patients should be dialyzed to correct metabolic abnormalities and to lower the ethylene glycol concentrations below 50 mg/dL. Discontinuation of Fomepizole Injection Treatment : Treatment with fomepizole injection may be discontinued when ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH.

Dosing of Fomepizole Injection A loading dose of 15 mg/kg should be administered, followed by doses of 10 mg/kg every 12 hours for 4 doses, then 15 mg/kg every 12 hours thereafter until ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH. All doses should be administered as a slow intravenous infusion over 30 minutes (see Administration ). Dosage with Renal Dialysis : Fomepizole injection is dialyzable and the frequency of dosing should be increased to every 4 hours during hemodialysis.

Fomepizole Injection Dosing in Patients Requiring Hemodialysis DOSE AT THE BEGINNING OF HEMODIALYSIS DOSING DURING HEMODIALYSIS If <6 hours since last fomepizole injection dose If ≥6 hours since last fomepizole injection dose Do not administer dose Administer next scheduled dose Dose every 4 hours DOSING AT THE TIME HEMODIALYSIS IS COMPLETED Time between last dose and the end of hemodialysis <1 hour Do not administer dose at the end of hemodialysis 1–3 hours Administer 1/2 of next scheduled dose >3 hours Administer next scheduled dose MAINTENANCE DOSING OFF HEMODIALYSIS Give next scheduled dose 12 hours from last dose administered Administration : Fomepizole injection solidifies at temperatures less than 25° C (77° F).

If the fomepizole injection solution has become solid in the vial, the solution… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 21 words ▾

CONTRAINDICATIONS Fomepizole injection should not be administered to patients with a documented serious hypersensitivity reaction to fomepizole injection or other pyrazoles.

🤒 Adverse Reactions 147 words ▾

ADVERSE REACTIONS The most frequent adverse events reported as drug-related or unknown relationship to study drug in the 78 patients and 63 normal volunteers who received fomepizole injection were headache (14%), nausea (11%), and dizziness, increased drowsiness, and bad taste/metallic taste (6% each). All other adverse events in this population were reported in approximately 3% or fewer of those receiving fomepizole and were as follows: Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during fomepizole injection, inflammation at injection site, lumbalgia/backache, hangover Cardiovascular: Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension Gastrointestinal: Vomiting, diarrhea, dyspepsia, heartburn, decreased appetite, transient transaminitis Hemic/Lymphatic: Eosinophilia/hypereosinophilia, lymphangitis, disseminated intravascular coagulation, anemia Nervous: Lightheadedness, seizure, agitation, feeling drunk, facial flush, vertigo, nystagmus, anxiety, “felt strange”, decreased environmental awareness Respiratory: Hiccups, pharyngitis Skin/Appendages: Application site reaction, rash Special Senses: Abnormal smell, speech/visual disturbances, transient blurred vision, roar in ear Urogenital: Anuria

🔄 Drug Interactions 78 words ▾

Drug Interactions Drug Interactions Oral doses of fomepizole (10-20 mg/kg), via alcohol dehydrogenase inhibition, significantly reduced the rate of elimination of ethanol (by approximately 40%) given to healthy volunteers in moderate doses. Similarly, ethanol decreased the rate of elimination of fomepizole (by approximately 50%) by the same mechanism. Reciprocal interactions may occur with concomitant use of fomepizole and drugs that increase or inhibit the cytochrome P450 system (e.g., phenytoin, carbamazepine, cimetidine, ketoconazole), though this has not been studied.

🤰 Pregnancy 45 words ▾

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

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 12 words ▾

Geriatric Use Safety and effectiveness in geriatric patients have not been established.

🆘 Overdosage 65 words ▾

OVERDOSAGE Nausea, dizziness, and vertigo were noted in healthy volunteers receiving 50 and 100 mg/kg doses of fomepizole (at plasma concentrations of 290-520 µmol/L, 23.8-42.6 mg/L). These doses are 3-6 times the recommended dose. This dose-dependent CNS effect was short-lived in most subjects and lasted up to 30 hours in one subject. Fomepizole is dialyzable, and hemodialysis may be useful in treating cases of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Mechanism of Action : Fomepizole is a competitive inhibitor of alcohol dehydrogenase. Alcohol dehydrogenase catalyzes the oxidation of ethanol to acetaldehyde. Alcohol dehydrogenase also catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites.

Ethylene glycol, the main component of most antifreezes and coolants, is metabolized to glycoaldehyde, which undergoes subsequent sequential oxidations to yield glycolate, glyoxylate, and oxalate. Glycolate and oxalate are the metabolic by-products primarily responsible for the metabolic acidosis and renal damage seen in ethylene glycol toxicosis. The lethal dose of ethylene glycol in humans is approximately 1.4 mL/kg.

Methanol, the main component of windshield wiper fluid, is slowly metabolized via alcohol dehydrogenase to formaldehyde with subsequent oxidation via formaldehyde dehydrogenase to yield formic acid. Formic acid is primarily responsible for the metabolic acidosis and visual disturbances (e.g., decreased visual acuity and potential blindness) associated with methanol poisoning. A lethal dose of methanol in humans is approximately 1-2 mL/kg.

Fomepizole has been shown in vitro to block alcohol dehydrogenase enzyme activity in dog, monkey, and human liver. The concentration of fomepizole at which alcohol dehydrogenase is inhibited by 50% in vitro is approximately 0.1 µmol/L. In a study of dogs given a lethal dose of ethylene glycol, three animals each were administered fomepizole, ethanol, or left untreated (control group).

The three animals in the untreated group became progressively obtunded, moribund, and died. At necropsy, all three dogs had severe renal tubular damage. Fomepizole or ethanol, given 3 hours after ethylene glycol ingestion, attenuated the metabolic acidosis and prevented the renal tubular damage associated with ethylene glycol intoxication.

Several studies have demonstrated that fomepizole plasma concentrations of approximately 10 µmol/L (0.82 mg/L) in monkeys are sufficient to inhibit methanol metabolism to formate, which is also mediated by alcohol dehydrogenase. Based on these results, concentrations of fomepizole in humans in the range of 100 to 300 µmol/L (8.6-24.6 mg/L) have been targeted to assure adequate plasma concentrations for the effective inhibition of alcohol dehydrogenase. In healthy volunteers, oral doses of fomepizole (10-20 mg/kg) significantly reduced the rate of elimination of moderate doses of ethanol, which is also metabolized through the action of alcohol dehydrogenase (see PRECAUTIONS, Drug Interactions ).

Pharmacokinetics The plasma half-life of fomepizole injection varies with dose, even in patients with normal renal function, and has not been calculated. Distribution : After intravenous infusion, fomepizole rapidly distributes to total body water. The volume of distribution is between

0.6 L/kg and

1.02L/kg. Metabolism : In healthy volunteers, only 1-3.5% of the administered dose of fomepizole (7-20 mg/kg oral and IV) was excreted unchanged in the urine, indicating that metabolism is the major route of elimination. In humans, the primary metabolite of fomepizole is 4-carboxypyrazole (approximately 80-85% of administered dose), which is excreted in the urine.

Other metabolites of fomepizole observed in the urine are 4-hydroxymethylpyrazole and the N-glucuronide conjugates of 4-carboxypyrazole and 4-hydroxymethylpyrazole. Excretion: The elimination of fomepizole is best characterized by Michaelis-Menten kinetics after acute doses, with saturable elimination occurring at therapeutic blood concentrations [100-300 µmol/L, 8.2-24.6 mg/L]. With multiple doses, fomepizole rapidly induces its own metabolism via the cytochrome P450 mixed-function oxidase system, which produces a significant increase in the elimination rate after about 30-40 hours.

After enzyme induction, elimination follows first-order kinetics. Special Populations: Geriatric Use Fomepizole injection has… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 65 words ▾

HOW SUPPLIED Fomepizole is supplied as a sterile, preservative-free solution for intravenous use as: Supplied in single vial cartons. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 0517-0710-88 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: American Regent, Inc. Shirley, NY 11967 RQ1088-B Revised: November 2020 Novaplus is a registered trademark of Vizient, Inc. Novaplus Logo

📋 Description 95 words ▾

DESCRIPTION Fomepizole injection is a competitive inhibitor of alcohol dehydrogenase. The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula C 4 H 6 N 2 and a molecular weight of 82.1.

The structural formula is: It is a clear to yellow liquid at room temperature. Its melting point is 25° C (77° F) and it may present in a solid form at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform.

Each vial contains 1.5 mL (1 g/mL) of fomepizole. Image from Drug Label Content

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Fomepizole injection should not be given undiluted or by bolus injection. Venous irritation and phlebosclerosis were noted in two of six normal volunteers given bolus injections (over 5 minutes) of fomepizole at a concentration of 25 mg/mL. Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) when diluting or administering fomepizole injection.

Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate. Minor allergic reactions (mild rash, eosinophilia) have been reported in a few patients receiving fomepizole (see ADVERSE REACTIONS ). Therefore, patients should be monitored for signs of allergic reactions.

Laboratory Tests In addition to specific antidote treatment with fomepizole, patients intoxicated with ethylene glycol or methanol must be managed for metabolic acidosis, acute renal failure (ethylene glycol), adult respiratory distress syndrome, visual disturbances (methanol), and hypocalcemia. Fluid therapy and sodium bicarbonate administration are potential supportive therapies. In addition, potassium and calcium supplementation and oxygen administration are usually necessary.

Hemodialysis is necessary in the anuric patient, or in patients with severe metabolic acidosis or azotemia (see DOSAGE AND ADMINISTRATION ). Treatment success should be assessed by frequent measurements of blood gases, pH, electrolytes, BUN, creatinine, and urinalysis, in addition to other laboratory tests as indicated by individual patient conditions. At frequent intervals throughout the treatment, patients poisoned with ethylene glycol should be monitored for ethylene glycol concentrations in serum and urine, and the presence of urinary oxalate crystals.

Similarly, serum methanol concentrations should be monitored in patients poisoned with methanol. Electrocardiography should be performed because acidosis and electrolyte imbalances can affect the cardiovascular system. In the comatose patient, electroencephalography may also be required.

In addition, hepatic enzymes and white blood cell counts should be monitored during treatment, as transient increases in serum transaminase concentrations and eosinophilia have been noted with repeated fomepizole dosing. Drug Interactions Drug Interactions Oral doses of fomepizole (10-20 mg/kg), via alcohol dehydrogenase inhibition, significantly reduced the rate of elimination of ethanol (by approximately 40%) given to healthy volunteers in moderate doses. Similarly, ethanol decreased the rate of elimination of fomepizole (by approximately 50%) by the same mechanism.

Reciprocal interactions may occur with concomitant use of fomepizole and drugs that increase or inhibit the cytochrome P450 system (e.g., phenytoin, carbamazepine, cimetidine, ketoconazole), though this has not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies performed in animals to evaluate carcinogenic potential. There was a positive Ames test result in the Escherichia coli tester strain WP2uvrA and the Salmonella typhimurium tester strain TA102 in the absence of metabolic activation.

There was no evidence of a clastogenic effect in the in vivo mouse micronucleus assay. In rats, fomepizole (110 mg/kg) administered orally for 40 to 42 days resulted in decreased testicular mass (approximately 8% reduction). This dose is approximately 0.6 times the human maximum daily exposure based on surface area (mg/m2).

This reduction was similar for rats treated with either ethanol or fomepizole alone. When fomepizole was given in combination with ethanol, the decrease in testicular mass was significantly greater (approximately 30% reduction) compared to those rats treated exclusively with fomepizole or ethanol. Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with fomepizole.

It is also not known whether fomepizole can ca… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 33 words ▾

Nursing Mothers It is not known whether fomepizole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when fomepizole is administered to a nursing woman.

🧬 Pharmacokinetics 180 words ▾

Pharmacokinetics The plasma half-life of fomepizole injection varies with dose, even in patients with normal renal function, and has not been calculated. Distribution : After intravenous infusion, fomepizole rapidly distributes to total body water. The volume of distribution is between

0.6 L/kg and

1.02L/kg. Metabolism : In healthy volunteers, only 1-3.5% of the administered dose of fomepizole (7-20 mg/kg oral and IV) was excreted unchanged in the urine, indicating that metabolism is the major route of elimination. In humans, the primary metabolite of fomepizole is 4-carboxypyrazole (approximately 80-85% of administered dose), which is excreted in the urine.

Other metabolites of fomepizole observed in the urine are 4-hydroxymethylpyrazole and the N-glucuronide conjugates of 4-carboxypyrazole and 4-hydroxymethylpyrazole. Excretion: The elimination of fomepizole is best characterized by Michaelis-Menten kinetics after acute doses, with saturable elimination occurring at therapeutic blood concentrations [100-300 µmol/L, 8.2-24.6 mg/L]. With multiple doses, fomepizole rapidly induces its own metabolism via the cytochrome P450 mixed-function oxidase system, which produces a significant increase in the elimination rate after about 30-40 hours.

After enzyme induction, elimination follows first-order kinetics. Special Populations:

🔬 Clinical Studies 207 words ▾

Clinical Studies The efficacy of fomepizole in the treatment of ethylene glycol and methanol intoxication was studied in two prospective, U.S. clinical trials without concomitant control groups. Fourteen of 16 patients in the ethylene glycol trial and 7 of 11 patients in the methanol trial underwent hemodialysis because of severe intoxication (see DOSAGE AND ADMINISTRATION). All patients received fomepizole shortly after admission.

The results of these two studies provide evidence that fomepizole blocks ethylene glycol and methanol metabolism mediated by alcohol dehydrogenase in the clinical setting. In both studies, plasma concentrations of toxic metabolites of ethylene glycol and methanol failed to rise in the initial phases of treatment. The relationship to fomepizole therapy, however, was confounded by hemodialysis and significant blood ethanol concentrations in many of the patients.

Nevertheless, in the post-dialysis period(s), when ethanol concentrations were insignificant and the concentrations of ethylene glycol or methanol were > 20 mg/dL, the administration of fomepizole injection alone blocked any rise in glycolate or formate concentrations, respectively. In a separate French trial, 5 patients presented with ethylene glycol concentrations ranging from 46.5 to 345 mg/dL, insignificant ethanol blood concentrations, and normal renal function. These patients were treated with fomepizole alone without hemodialysis, and none developed signs of renal injury.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 138 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies performed in animals to evaluate carcinogenic potential. There was a positive Ames test result in the Escherichia coli tester strain WP2uvrA and the Salmonella typhimurium tester strain TA102 in the absence of metabolic activation. There was no evidence of a clastogenic effect in the in vivo mouse micronucleus assay.

In rats, fomepizole (110 mg/kg) administered orally for 40 to 42 days resulted in decreased testicular mass (approximately 8% reduction). This dose is approximately 0.6 times the human maximum daily exposure based on surface area (mg/m2). This reduction was similar for rats treated with either ethanol or fomepizole alone.

When fomepizole was given in combination with ethanol, the decrease in testicular mass was significantly greater (approximately 30% reduction) compared to those rats treated exclusively with fomepizole or ethanol.

📄 Package Label / Principal Display Panel 101 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0517-0710-88 Rx Only Fomepizole Injection For intravenous infusion only 1.5 g/1.5mL (1 g/mL) Single-Dose Vial Caution: Must be diluted before use. Caution: Do not use with polycarbonate-containing syringes or needles. NDC 0517-0710-88 Fomepizole Injection For intravenous infusion only 1.5 g/1.5mL (1 g/mL) One Single-Dose Vial Caution: Must be diluted before use.

Caution: Do not use with polycarbonate-containing syringes or needles. Rx Only Manufactured by: American Regent, Inc. Shirley, NY 11967 Novaplus is a registered trademark of Vizient, Inc.

Container Label - Novaplus Novaplus logo in color Carton Labeling - Novaplus

Serialization Label Serialization Label for Novaplus

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by American Regent, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00517-0710-88). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
American Regent, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1451 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00517-0650-01 · American 00517-0720-01 · American →
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.