Iodixanol vs. Visipaque: Understanding the FDA-Approved Generic Alternative

Written by: Spectrum Xray /
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October 13, 2026

Iodixanol vs. Visipaque is a comparison more purchasing teams are making as they review contrast media spend. Visipaque is a familiar name in CT imaging, angiography, and cardiovascular procedures, and many facilities still order it by brand without realizing an FDA-approved generic version of the same active ingredient is now available.

Below, we explain what Visipaque is, how generic iodixanol compares in concentration and FDA equivalence rating, and what imaging centers and hospitals should weigh before adding a second source to their CT contrast media orders.

Key Takeaways

  • Iodixanol vs. Visipaque is a generic-versus-brand comparison. Visipaque is GE HealthCare’s brand name for iodixanol injection, so both products share the same active ingredient.
  • The FDA Orange Book lists generic iodixanol 55% (270 mg iodine/mL) and 65.2% (320 mg iodine/mL) with an AP therapeutic-equivalence rating.
  • Match concentration, container size, and labeled indication before adding generic iodixanol to a contrast media order.
  • A second FDA-approved source can lower acquisition costs and give purchasing teams a backup when iodinated contrast supply tightens.
  • Final product selection belongs to each facility’s clinical, pharmacy, and purchasing staff, guided by the approved labeling and institutional protocols.

Iodixanol vs. Visipaque: A Generic Alternative Is Available

Healthcare facilities looking for Visipaque® may now have another purchasing option: iodixanol injection, the FDA-approved generic alternative to brand-name Visipaque.

Visipaque is a well-known iodinated contrast agent, part of a broader group of contrast materials used in diagnostic imaging. But what some imaging centers, hospitals, outpatient facilities, and purchasing departments may not realize is that iodixanol is the active ingredient in Visipaque.

For facilities looking to control contrast-media costs while maintaining access to FDA-approved products, generic iodixanol may be worth considering.

Fresenius Kabi has marketed this generic iodixanol injection in the United States since 2022, in both the 270 and 320 mg iodine/mL strengths. For purchasing teams, the choice is no longer limited to a single branded product when an order calls for an iso-osmolar contrast agent.

Iodixanol vs. Visipaque: Understanding the Brand Name

Visipaque is GE HealthCare’s brand name for iodixanol injection, an iodinated radiographic contrast agent.

Iodixanol is a nonionic, dimeric, iso-osmolar contrast agent. Its osmolality is 290 mOsm/kg water at both strengths, which matches the osmolality of blood. That sets it apart from older ionic contrast agents, which are high-osmolar and have largely been replaced by nonionic agents for intravascular use.

Visipaque is available in concentrations of:

  • Visipaque 270 – 270 mg iodine/mL
  • Visipaque 320 – 320 mg iodine/mL

Depending on the concentration, Visipaque is indicated for a range of intravascular diagnostic imaging procedures, including certain CT, angiographic, cardiovascular, and other radiographic examinations. Because iodine absorbs X-rays, iodixanol is used for X-ray-based studies such as CT scans and angiography. It is not used for magnetic resonance imaging (MRI), which relies on gadolinium-based agents, or for contrast-enhanced ultrasound, which uses microbubble agents.

The table below summarizes the adult intravascular uses on current Visipaque labeling. Pediatric uses vary by age, so check the full prescribing information before ordering.

ConcentrationIntra-arterial usesIntravenous uses
270 mg iodine/mLIntra-arterial digital subtraction angiographyCT of the head and body, excretory urography, peripheral venography
320 mg iodine/mLAngiocardiography, plus peripheral, visceral, and cerebral arteriographyCT of the head and body, excretory urography, coronary CT angiography

In other words, when a facility purchases Visipaque, the active ingredient it is purchasing is iodixanol.

Generic Iodixanol Explained

Generic iodixanol is an FDA-approved iodixanol injection available as an alternative to brand-name Visipaque.

The FDA Orange Book lists iodixanol injection from Hengrui Pharma alongside Visipaque in both strengths:

  • Iodixanol 55% – corresponding to 270 mg iodine/mL
  • Iodixanol 65.2% – corresponding to 320 mg iodine/mL

The FDA Orange Book lists these iodixanol products with an AP therapeutic-equivalence rating to the reference product.

This is an important distinction for healthcare purchasing departments evaluating a generic Visipaque alternative.

An AP rating means the FDA considers the generic injectable therapeutically equivalent to the reference product. In practice, it is expected to produce the same clinical effect and safety profile when used under the conditions on its labeling. Fresenius Kabi’s launch announcement also describes the product as preservative-free and supplied in polymer bottles made without natural rubber latex.

The Difference Between Iodixanol and Visipaque

The biggest difference is straightforward:

Visipaque is a brand name. Iodixanol is the active ingredient and is also available as an FDA-approved generic product.

For healthcare facilities, this creates another sourcing option when purchasing iodixanol contrast media.

Instead of limiting a purchasing department’s search to “Visipaque,” facilities can also evaluate FDA-approved generic iodixanol products in the corresponding concentration and presentation.

Here is how the two compare on the points purchasing and pharmacy teams ask about most.

FeatureVisipaqueGeneric Iodixanol
Active ingredientIodixanolIodixanol
Product typeBrand-name reference product from GE HealthCareFDA-approved generic (ANDA 214271), marketed in the U.S. by Fresenius Kabi
Strengths270 and 320 mg iodine/mL55% (270 mg iodine/mL) and 65.2% (320 mg iodine/mL)
OsmolalityIso-osmolar, 290 mOsm/kg waterIso-osmolar dimeric formulation
FDA equivalenceReference productAP therapeutic-equivalence rating
ContainersPolymer bottles, 50 to 200 mL270: 100 and 150 mL bottles; 320: 50, 100, 150, and 200 mL bottles
Purchasing roleFamiliar brand, often on existing contractsSecond source for cost and supply planning

This may provide benefits related to:

  • Cost savings: Generic products may provide opportunities for facilities to reduce contrast-media acquisition costs.
  • Purchasing flexibility: Adding another approved source can give purchasing departments additional options rather than relying exclusively on a single branded product.
  • Supply-chain flexibility: Having qualified alternative suppliers may be particularly useful when contrast-media availability is constrained.
  • Standardization opportunities: Multi-location imaging organizations may be able to evaluate generic iodixanol as part of a broader contrast-media purchasing strategy.

Actual product selection should always be made by the facility’s qualified clinical, pharmacy, and purchasing personnel based on the approved labeling, institutional protocols, and applicable requirements.

Iodixanol vs. Visipaque: Clinical and Regulatory Differences

For radiology departments, the regulatory difference comes down to the approval pathway. Visipaque is approved under a new drug application (NDA 020351) and serves as the reference product, while generic iodixanol is approved under an abbreviated new drug application (ANDA 214271) with an AP rating. 

Clinically, both contain iodixanol at the same strengths, so properties such as osmolality, viscosity, and the boxed warning against intrathecal use follow the same active ingredient. Each product still carries its own labeling, so confirm that the indications listed for the generic cover the procedures your department performs. Both labels carry warnings and precautions for the same active ingredient, including hypersensitivity and other adverse reactions. Before the scan, healthcare providers screen patients for kidney function, thyroid disease, and other medical conditions that can raise risk.

Generic Iodixanol FDA Approval and AP Rating

The U.S. Food and Drug Administration’s Orange Book lists iodixanol injection manufactured by Hengrui Pharma as an approved prescription drug product.

The Orange Book lists the product under ANDA 214271, with FDA approval dated May 19, 2022.

The FDA lists the products as:

  • Iodixanol 55%
  • Iodixanol 65.2%

The same Orange Book entry lists Visipaque 270 at 55% and Visipaque 320 at 65.2%.

For facilities evaluating a generic Visipaque option, this provides an FDA-approved iodixanol alternative to consider.

Purchasing teams can confirm the current listing by searching “iodixanol” in the FDA Orange Book online. Recording the TE code before a formulary review gives pharmacy and clinical staff a documented basis for the substitution discussion. Our contrast media supplier checklist covers other quality and compliance points to verify with any supplier.

Why Imaging Centers Are Looking at Generic Contrast Media

Contrast media represent a significant recurring expense for many imaging centers, hospitals, catheterization labs, and other healthcare facilities.

Even relatively small differences in acquisition cost can become meaningful when multiplied across hundreds or thousands of imaging exams.

Generic contrast media can therefore give purchasing departments another opportunity to evaluate their costs without simply accepting existing brand-name purchasing arrangements.

Supply matters as much as price. In 2022, a global shortage of iodinated contrast media disrupted CT and angiography schedules at hospitals across the country, and facilities tied to one product had few options. A second FDA-approved iodixanol source gives teams more room to plan, and it adds leverage when reviewing contrast media pricing with suppliers.

This can be particularly relevant for:

  • Independent imaging centers
  • Hospital imaging departments
  • Radiology groups
  • Cardiology and catheterization laboratories
  • Outpatient diagnostic centers
  • Ambulatory surgery centers
  • Multi-location imaging organizations
  • Healthcare systems

Facilities should evaluate product labeling, clinical protocols, contracting requirements, availability, and total acquisition cost when considering any change in contrast media.

Choosing a Visipaque Alternative for Your Facility

If your facility currently purchases Visipaque 270 or Visipaque 320, Spectrum Medical Imaging Co. can help you evaluate available iodixanol options.

Spectrum Medical Imaging Co. supplies contrast media to imaging centers and healthcare facilities throughout the United States. With more than 42 years in the medical imaging industry, we work with independent imaging centers, hospitals, health systems, and multi-location healthcare organizations to provide reliable access to contrast media and related imaging supplies.

Most facilities follow a short internal review before adding a generic to their contrast media orders. The steps below reflect common practice. Your institution’s own policies take priority.

StepWhat to CheckWho Is Usually Involved
1. Match the productConcentration (270 or 320 mg iodine/mL), bottle size, and single-dose or multiple-dose presentationPurchasing, pharmacy
2. Review the labelingIndications, dosing, warnings, and storage in the generic’s prescribing informationPharmacy, radiology management
3. Confirm workflow fitInjector setup, contrast administration steps, bottle handling, and contrast warming practicesLead technologists, imaging managers
4. Compare total costUnit price, volume tiers, freight, and contract termsPurchasing, finance
5. Plan the changeoverFormulary updates, inventory transition, and staff communicationPharmacy, imaging operations

Our team can help facilities evaluate:

  • Visipaque and iodixanol purchasing options
  • Iodixanol 270 mg iodine/mL
  • Iodixanol 320 mg iodine/mL
  • Available vial and bottle configurations
  • Bulk and volume pricing
  • Contrast-media availability
  • Injector syringes and disposables
  • Other CT and magnetic resonance contrast media

Ask Spectrum Medical Imaging Co. About Generic Iodixanol Pricing

If you are currently purchasing Visipaque, ask Spectrum Medical Imaging Co. about FDA-approved generic iodixanol.

Our team can review your current Visipaque usage, concentration, package size, and monthly volume and provide available iodixanol options and pricing.

For high-volume facilities and multi-location imaging organizations, contact Spectrum Medical Imaging Co. to discuss volume purchasing opportunities and ongoing supply programs.

A recent invoice or usage report is the fastest starting point. We line up matching iodixanol options by concentration and bottle size, so your team compares like-for-like instead of guessing.

Contact Spectrum Medical Imaging Co. Today for Current Iodixanol Availability and Pricing

Your contrast media budget should not depend on a single brand. For over 42 years, Spectrum Medical Imaging Co. has helped hospitals, imaging centers, and health systems buy contrast media with confidence, and our specialists carry both GE HealthCare Visipaque and Fresenius Kabi generic iodixanol. That means you get a straight answer on both products from one team.

Call 800-859-6162 to speak with our sales team today, or request a quote online, and a sales advisor will contact you within 24 hours. Share your current concentration, bottle size, and monthly volume, and we will send back available iodixanol options and pricing side by side, ready for your pharmacy and purchasing review. Learn more about Spectrum Medical Imaging Co. and how we support facilities nationwide.

Serving imaging centers, hospitals, radiology practices, outpatient facilities, and healthcare organizations throughout Los Angeles, California, and nationwide.

Frequently Asked Questions

Is generic iodixanol the same as Visipaque?

Generic iodixanol contains the same active ingredient as Visipaque, at the same 270 and 320 mg iodine/mL strengths. The FDA Orange Book lists the Hengrui Pharma product with an AP rating, which means the FDA considers it therapeutically equivalent to the reference product. In the United States, Fresenius Kabi markets this generic. Packaging, container design, and labeling details can differ, so review the generic’s prescribing information before ordering.

Can a hospital switch from Visipaque to generic iodixanol?

A hospital can add generic iodixanol to its orders once its clinical, pharmacy, and purchasing teams approve the change. The AP rating supports substitution, and most pharmacy and therapeutics committees still confirm the match in concentration, indication, and presentation. Imaging teams should also check how the new bottles fit their injector and warming workflow. Spectrum Medical Imaging Co. can supply product details and pricing to support that review.

What is iodixanol used for in medical imaging?

Iodixanol is an iodinated contrast agent given intra-arterially or intravenously so blood vessels and organs show more clearly on X-ray-based medical images. Visipaque labeling covers procedures such as CT of the head and body, coronary CT angiography, angiocardiography, arteriography, and excretory urography, depending on concentration. The labeling carries a boxed warning that iodixanol is not for intrathecal use. The generic’s labeling lists its own approved uses, which teams should match to their protocols.

Is generic iodixanol cheaper than Visipaque?

Generic iodixanol can give facilities a way to lower contrast media acquisition costs, but actual pricing depends on volume, contract terms, and supplier. Small per-bottle differences add up across hundreds or thousands of procedures each year. The most accurate comparison uses your facility’s real usage by concentration and bottle size. Spectrum Medical Imaging Co. can quote both products side by side so your team sees the difference before making a change.

What is the difference between iodixanol and iohexol?

Iodixanol and iohexol are both nonionic iodinated contrast agents, but they differ in structure and osmolality. Iodixanol, sold as Visipaque and as a generic, is a dimer that is iso-osmolar to blood at 290 mOsm/kg water. Iohexol, sold as Omnipaque, is a monomer classified as a low-osmolar contrast agent. Iodixanol is also more viscous at comparable iodine concentrations, which affects injection rates and warming practices. Clinical teams choose between them based on labeling, patient factors such as a history of contrast reactions, and procedure type.

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