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    Also known as: Gadoversetamide, Gadoversetamide (200 mg), 131069-91-5, Rlm74t3z9d, Mp-1177, (n,n-bis(2-((carboxymethyl)(((2-methoxyethyl)carbamoyl)methyl)amino)ethyl)glycinato(3-))gadolinium
    Molecular Formula
    C20H34GdN5O10
    Molecular Weight
    661.8  g/mol
    InChI Key
    HBEAOBRDTOXWRZ-UHFFFAOYSA-K
    Gadoversetamide
    Gadoversetamide is a paramagnetic extracellular magnetic resonance imaging (MRI) contrast agent that facilitates visualization of abnormal vascularity. When placed in a magnetic field, gadoversetamide decreases T1 (spin-lattice or longitudinal relaxation time) and T2 (spin-spin or transverse relaxation time) values in tissues where it accumulates. At the recommended dose, the effect is primarily on T1 relaxation time, and produces an increase in signal intensity. Gadoversetamide does not cross the intact blood-brain barrier. However, abnormal vascularity or disruption of the blood-brain barrier allows accumulation of gadoversetamide. (NCI05)
    1 2D Structure

    Gadoversetamide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[bis[2-[carboxylatomethyl-[2-(2-methoxyethylamino)-2-oxoethyl]amino]ethyl]amino]acetate;gadolinium(3+)
    2.1.2 InChI
    InChI=1S/C20H37N5O10.Gd/c1-34-9-3-21-16(26)11-24(14-19(30)31)7-5-23(13-18(28)29)6-8-25(15-20(32)33)12-17(27)22-4-10-35-2;/h3-15H2,1-2H3,(H,21,26)(H,22,27)(H,28,29)(H,30,31)(H,32,33);/q;+3/p-3
    2.1.3 InChI Key
    HBEAOBRDTOXWRZ-UHFFFAOYSA-K
    2.1.4 Canonical SMILES
    COCCNC(=O)CN(CCN(CCN(CC(=O)NCCOC)CC(=O)[O-])CC(=O)[O-])CC(=O)[O-].[Gd+3]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Gadoversetamide

    2.2.2 Depositor-Supplied Synonyms

    1. Gadoversetamide

    2. Gadoversetamide (200 Mg)

    3. 131069-91-5

    4. Rlm74t3z9d

    5. Mp-1177

    6. (n,n-bis(2-((carboxymethyl)(((2-methoxyethyl)carbamoyl)methyl)amino)ethyl)glycinato(3-))gadolinium

    7. Unii-rlm74t3z9d

    8. Optimark In Plastic Container

    9. Hsdb 7550

    10. Gadoversetamide [usan:usp:inn:ban]

    11. (8,11-bis(carboxymethyl)-14-(2-((2-methoxyethyl)amino)-2-oxoethyl)-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)), Gadolinium

    12. Dtxsid10156865

    13. (gadoversetamide) (8,11-bis(carboxymethyl)-14-(2-((2-methoxyethyl)amino)-2-oxoethyl)-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)), Gadolinium

    2.3 Create Date
    2006-04-28
    3 Chemical and Physical Properties
    Molecular Weight 661.8 g/mol
    Molecular Formula C20H34GdN5O10
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count13
    Rotatable Bond Count6
    Exact Mass662.15468 g/mol
    Monoisotopic Mass662.15468 g/mol
    Topological Polar Surface Area207 Ų
    Heavy Atom Count36
    Formal Charge0
    Complexity637
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameOptimark
    Active IngredientGadoversetamide
    Dosage FormInjectable
    RouteInjection
    Strength1654.5mg/5ml (330.9mg/ml); 6618mg/20ml (330.9mg/ml); 4963.5mg/15ml (330.9mg/ml); 3309mg/10ml (330.9mg/ml); 16.545gm/50ml (330.9mg/ml)
    Market StatusPrescription
    CompanyMallinckrodt

    2 of 4  
    Drug NameOptimark in plastic container
    PubMed HealthGadoversetamide (Injection)
    Drug ClassesDiagnostic Agent, Radiological Contrast Media, Radiological Ionic Contrast Media, Radiological Non-Ionic Contrast Media
    Drug LabelOptimark (gadoversetamide) injection is a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for intravenous injection.Optimark injection is provided as a sterile, preservative-free, nonpyrogeni...
    Active IngredientGadoversetamide
    Dosage FormInjectable
    RouteInjection
    Strength6618mg/20ml (330.9mg/ml); 4963.5mg/15ml (330.9mg/ml); 3309mg/10ml (330.9mg/ml); 9927mg/30ml (330.9mg/ml)
    Market StatusPrescription
    CompanyMallinckrodt

    3 of 4  
    Drug NameOptimark
    Active IngredientGadoversetamide
    Dosage FormInjectable
    RouteInjection
    Strength1654.5mg/5ml (330.9mg/ml); 6618mg/20ml (330.9mg/ml); 4963.5mg/15ml (330.9mg/ml); 3309mg/10ml (330.9mg/ml); 16.545gm/50ml (330.9mg/ml)
    Market StatusPrescription
    CompanyMallinckrodt

    4 of 4  
    Drug NameOptimark in plastic container
    PubMed HealthGadoversetamide (Injection)
    Drug ClassesDiagnostic Agent, Radiological Contrast Media, Radiological Ionic Contrast Media, Radiological Non-Ionic Contrast Media
    Drug LabelOptimark (gadoversetamide) injection is a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for intravenous injection.Optimark injection is provided as a sterile, preservative-free, nonpyrogeni...
    Active IngredientGadoversetamide
    Dosage FormInjectable
    RouteInjection
    Strength6618mg/20ml (330.9mg/ml); 4963.5mg/15ml (330.9mg/ml); 3309mg/10ml (330.9mg/ml); 9927mg/30ml (330.9mg/ml)
    Market StatusPrescription
    CompanyMallinckrodt

    4.2 Therapeutic Uses

    Contrast Media

    National Library of Medicine's Medical Subject Headings. Gadoversetamide. Online file (MeSH, 2014). Available from, as of October 23, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Optimark is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    Optimark is indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver of patients who are highly suspect for liver structural abnormalities on computed tomography. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: NEPHROGENIC SYSTEMIC FIBROSIS. Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Do not administer Optimark to patients with: chronic, severe kidney disease (GFR <30 mL/min/1.73 sq m), or acute kidney injury. Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. Do not exceed the recommended Optimark dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR <30 mL/min/1.73sq m) as well as patients with acute kidney injury. Do not administer Optimark to these patients. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73 sq m) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73 sq m). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. ... Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury, or drug-induced kidney toxicity. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronic kidney disease (e.g., age >60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing. Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. When administering Optimark, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug prior to any re-administration.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    Severe hypersensitivity reactions including anaphylaxis have been observed with administration of gadolinium products including Optimark. Before administering Optimark ensure the availability of resuscitation equipment and personnel trained in resuscitation techniques. Patients with a history of allergy, drug reactions or other hypersensitivity-like disorders may be at greater risk and should be closely observed during the procedure and for several hours after drug administration. If a reaction occurs, stop Optimark and immediately begin appropriate therapy including resuscitation.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    For more Drug Warnings (Complete) data for GADOVERSETAMIDE (14 total), please visit the HSDB record page.

    4.4 Drug Indication

    This medicinal product is for diagnostic use only.

    Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Contrast Media

    Substances used to allow enhanced visualization of tissues. (See all compounds classified as Contrast Media.)

    5.2 ATC Code

    V08CA06

    V - Various

    V08 - Contrast media

    V08C - Magnetic resonance imaging contrast media

    V08CA - Paramagnetic contrast media

    V08CA06 - Gadoversetamide

    5.3 Absorption, Distribution and Excretion

    Gadoversetamide (0.1 mmol/kg) is eliminated primarily in the urine with 95.5 + or - 17.4% (mean + or - SD) of the administered dose eliminated by 24 hours. Animal data demonstrated that insignificant levels of 153Gd-labeled gadoversetamide are eliminated via the feces. In experimentally induced anephria in the rat, hepatobiliary excretion did not significantly compensate for the absence of urinary elimination. The renal and plasma clearance rates of gadoversetamide in normal subjects are similar (69 + or - 15.4 and 72 + or - 16.3 mL/hr/kg, respectively) indicating that the drug is cleared through the kidneys via glomerular filtration. Within the studied dose range (0.1 to 0.7 mmol/kg), the kinetics of gadoversetamide appear to be linear.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    The volume of distribution at steady state of gadoversetamide in normal subjects is 162 + or - 25 mL/kg, roughly equivalent to that of extracellular water.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    Radiolabeled gadoversetamide ((153)Gd) was excreted in the milk of lactating rats receiving a single intravenous dose of 0.1 mmol/kg.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    Optimark injection does not cross the intact blood brain barrier, and, therefore, does not accumulate in the normal brain or in lesions that may have a normal blood-brain barrier (eg, cysts, mature post-operative scars, etc.). However, disruption of the blood-brain barrier or abnormal vascularity allows accumulation of Optimark injection in the extravascular spaces of lesions such as neoplasms, abscesses, and subacute infarcts. The pharmacokinetic parameters of Optimark injection in various lesions are not known.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    For more Absorption, Distribution and Excretion (Complete) data for GADOVERSETAMIDE (6 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    Gadoversetamide is not metabolized.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    5.5 Biological Half-Life

    The pharmacokinetics of intravenously administered gadoversetamide in normal subjects conforms to a two-compartment open-model with mean distribution and elimination half-lives (reported as mean + or - SD) of about 13.3 + or - 6.8 and 103.6 + or - 19.5 minutes.

    NIH; DailyMed. Current Medication Information for Optimark (Gadoversetamide) Injection, Solution (Revised: October 2014). Available from, as of October 9, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=20372fd0-cd3c-47b2-bfc1-f5b8bc03ec0a

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 1654.5MG/5ML ...DOSAGE - INJECTABLE;INJECTION - 1654.5MG/5ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20937

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    DOSAGE - INJECTABLE;INJECTION - 3309MG/10ML (...DOSAGE - INJECTABLE;INJECTION - 3309MG/10ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20937

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    DOSAGE - INJECTABLE;INJECTION - 4963.5MG/15ML...DOSAGE - INJECTABLE;INJECTION - 4963.5MG/15ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20937

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    DOSAGE - INJECTABLE;INJECTION - 6618MG/20ML (...DOSAGE - INJECTABLE;INJECTION - 6618MG/20ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20937

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    DOSAGE - INJECTABLE;INJECTION - 16.545GM/50ML...DOSAGE - INJECTABLE;INJECTION - 16.545GM/50ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20975

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    DOSAGE - INJECTABLE;INJECTION - 3309MG/10ML (...DOSAGE - INJECTABLE;INJECTION - 3309MG/10ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20976

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    DOSAGE - INJECTABLE;INJECTION - 4963.5MG/15ML...DOSAGE - INJECTABLE;INJECTION - 4963.5MG/15ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20976

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    DOSAGE - INJECTABLE;INJECTION - 6618MG/20ML (...DOSAGE - INJECTABLE;INJECTION - 6618MG/20ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20976

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    DOSAGE - INJECTABLE;INJECTION - 9927MG/30ML (...DOSAGE - INJECTABLE;INJECTION - 9927MG/30ML (330.9MG/ML)

    USFDA APPLICATION NUMBER - 20976

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    ABOUT THIS PAGE

    Gadoversetamide Manufacturers

    A Gadoversetamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadoversetamide, including repackagers and relabelers. The FDA regulates Gadoversetamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadoversetamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    Gadoversetamide Suppliers

    A Gadoversetamide supplier is an individual or a company that provides Gadoversetamide active pharmaceutical ingredient (API) or Gadoversetamide finished formulations upon request. The Gadoversetamide suppliers may include Gadoversetamide API manufacturers, exporters, distributors and traders.

    click here to find a list of Gadoversetamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Gadoversetamide USDMF

    A Gadoversetamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadoversetamide active pharmaceutical ingredient (API) in detail. Different forms of Gadoversetamide DMFs exist exist since differing nations have different regulations, such as Gadoversetamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Gadoversetamide DMF submitted to regulatory agencies in the US is known as a USDMF. Gadoversetamide USDMF includes data on Gadoversetamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadoversetamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Gadoversetamide suppliers with USDMF on PharmaCompass.

    Gadoversetamide GMP

    Gadoversetamide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Gadoversetamide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Gadoversetamide GMP manufacturer or Gadoversetamide GMP API supplier for your needs.

    Gadoversetamide CoA

    A Gadoversetamide CoA (Certificate of Analysis) is a formal document that attests to Gadoversetamide's compliance with Gadoversetamide specifications and serves as a tool for batch-level quality control.

    Gadoversetamide CoA mostly includes findings from lab analyses of a specific batch. For each Gadoversetamide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Gadoversetamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Gadoversetamide EP), Gadoversetamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gadoversetamide USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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