Home › NDC Lookup › Ingredients › Iohexol › 80830-2467-02
Iohexol 300 mg/mL Injection, Solution — NDC 80830-2467-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Iohexol 300 mg/mL Injection, Solution — NDC 80830-2467-2 (Billing 80830-2467-02)

by Amneal Pharmaceuticals Private Limited · 10 BOTTLE, PLASTIC in 1 CARTON / 75 mL in 1 BOTTLE, PLASTIC

This is a package of Iohexol 300 mg/mL Injection, Solution from Amneal Pharmaceuticals Private Limited, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 80830-2467-02
🏷️ FDA NDC (as labeled) 80830-2467-2 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

⚠️
Other active recalls for Iohexol (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 24, 2026 — Presence of particulate matter (GE Healthcare Ireland Limited) · FDA recall D-0448-2026
Class II · Mar 24, 2026 — Presence of particulate matter (GE Healthcare Ireland Limited) · FDA recall D-0447-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80830-2467-2
Product NDC 80830-2467
11-digit billing NDC 80830246702
UNII 4419T9MX03
Application # ANDA217737
SPL Set ID ff9456ef-c45a-450d-9004-a684af2bcc59
Established class (EPC) Radiographic Contrast Agent
Mechanism of action X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-13
Route INTRA-ARTICULAR, INTRATHECAL, INTRAVASCULAR, INTRAVENOUS, ORAL, RECTAL
Dosage form INJECTION, SOLUTION
Substance IOHEXOL
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 000436
GCN 25521
HICL code 000151
Ingredient (HICL) Iohexol
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A6
Therapeutic class — intermediate (HIC2) Cardiovascular Diagnostic Agents
HIC3 code A6U
Therapeutic class — specific (HIC3) Cardiovascular Diagnostics-Radiopaque
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name IOHEXOL 300 MG/ML BOTTLE
FDB brand name Iohexol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 000436
  • GCN: 25521
  • HICL (First Databank): 000151
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 80830-2467-2 — a 5-4-1 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 package segment → 80830-2467-02. 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.

Clinical

Label name IOHEXOL 300 MG/ML BOTTLE Ingredient Iohexol
📗 Our plain-language guide HelloPharmacist
  • It is a contrast dye that makes X-rays and CT scans easier to read. Depending on the product, it can be used to look at the spine, blood vessels, urinary system, digestive tract, j...
  • Staff will give it by injection or by mouth, depending on the scan. The label advises staying well hydrated before and after an injection. Oraltag is mixed with a drink and taken 2...
  • How will I get it, and do I need to prepare?
  • They vary by route. After a spinal injection, headache, back pain and nausea are common. Swallowed forms often cause diarrhea, nausea or belly pain. Injection into a vessel can cau...
📖 Read our full Iohexol 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.

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.
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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80830-2467-02 You're viewing this Main listing 10 BOTTLE, PLASTIC in 1 CARTON / 75 mL in 1 BOTTLE, PLASTIC 2025-11-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Iohexol 300 mg/mL 80830-2468-02 Amneal 10 bottles — AP FDA listed —
Omnipaque 300 mg/mL 00407-1413-68 GE 10 bottles — — Discontinued —
Omnipaque 300 mg/mL 71872-7370-01 Medical 1 bottle — — FDA listed —
Iohexol 300 mg/mLthis 80830-2467-02 Amneal 10 bottles — AP FDA listed —
Iohexol 300 mg/mL 80830-2466-02 Amneal 10 bottles — 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

🏛️
2026
First FDA approval
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jul 2026 — those protections no longer apply, though a generic still needs FDA approval and a manufacturer to market it.
📅 FDA approved Jun 25, 2026 AP TE-rated RLD RS

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity CGT
2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
CGTFDA-granted marketing exclusivityJul 26, 2026
Common questions
Is there a generic version of IOHEXOL 300 MG/ML BOTTLE?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for IOHEXOL 300 MG/ML BOTTLE. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

Color yellow
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.

  • 0.1 mg / 1 mL UNII 25IH6R4SGF
    Edetate calcium disodium is a chelating agent, a chemical that binds to metal ions. It's used in some medications to prevent unwanted metals from interfering with the drug's stability and effectiveness.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 1.21 mg / 1 mL UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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 DailyMed — ingredient 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.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals Private Limited
Application holderAMNEAL EU LTD
FDA applicationANDA217737 (ANDA)
Labeler code80830
First marketedNov 2025
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.

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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 138 words ▾

WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF IOHEXOL INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the iohexol, iodine concentrations and presentations recommended for intrathecal procedure [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of iohexol of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia and brain edema [see Warnings and Precautions (5.1) ].

WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION OF IOHEXOL INJECTION 140 mg IODINE/mL and 350 mg IODINE/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures. Intrathecal administration of a wrong iodine concentration, even if inadvertent, may cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia and brain edema. ( 2.2 , 2.8 , 5.1 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity imaging procedures in adults and pediatric patients. ( 1 )

1.1Intrathecal Procedures ‡ Iohexol injection is indicated for: Myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older CT cisternography in adults and pediatric patients aged 2 weeks and older

1.2Intra-arterial Procedures ‡ Iohexol injection is indicated for: Cardiac ventriculography in adults and pediatric patients Aortography including studies of aorta and its branches in adults and pediatric patients Selective coronary arteriography in adults Cerebral arteriography in adults Peripheral arteriography in adults Intra-arterial digital subtraction angiography (IA-DSA) of the head, neck, abdominal, renal and peripheral vessels in adults Pulmonary angiography in pediatric patients

1.3Intravenous Procedures ‡ Iohexol injection is indicated for: Excretory urography in adults and pediatric patients CT of the head and body in adults and pediatric patients Peripheral venography (phlebography) in adults Intravenous digital subtraction angiography (IV-DSA) of the head, neck, abdominal, renal and peripheral vessels in adults

1.4Oral or Rectal Procedures ‡ Iohexol injection is indicated for: Radiographic examination of the gastrointestinal (GI) tract in adults and pediatric patients CT of the abdomen and pelvis in conjunction with intravenous administration of iohexol injection in adults and pediatric patients

1.5 Intraarticular Procedures ‡ Iohexol injection is indicated for: Arthrography in adults

1.6Body Cavity Procedures ‡ Iohexol injection is indicated for: Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP) in adults Herniography in adults Hysterosalpingography in adults Voiding cystourethrography (VCU) in pediatric patients ‡ Specific dosage forms, concentrations and presentations of iohexol are recommended for each type of imaging procedure [see Dosage and Administrations (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) and Warnings and Precautions (5.1 , 5.2) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION For each imaging procedure, specific dosage forms, concentrations and presentations are recommended. Individualize the concentration and volume according to the specific dosing tables and accounting for factors such as age, body weight and condition of the patient and the equipment and imaging technique used. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) See full prescribing information for complete dosing and administration information.

( 2 )

2.1Important Dosage and Administration Instructions Specific dosage forms, concentrations and presentations of iohexol are recommended for each type of imaging procedure [see Dosage and Administration (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) and Warnings and Precautions (5.1 , 5.2) ]. Individualize the volume, strength and rate of administration of iohexol injection according to the specific dosing tables [see Dosage and Administration (2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9) ] . Consider factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed.

Hydrate patients before and after administration of iohexol injection [see Warnings and Precautions (5.4) ]. Use aseptic technique for all handling and administration of iohexol injection. Administer iohexol injection at either body (37°C, 98.6°F) or room temperature (20° to 25°C, 68° to 77°F).

Do not mix iohexol injection with, or inject in intravenous lines containing, other drugs or total nutritional admixtures. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Each container of iohexol injection in single-dose container is intended for one procedure only.

Discard any unused portion.

2.2Recommended Dosage for Intrathecal Procedures in Adults The recommended doses for intrathecal procedures in adults are shown in Table 1. Administer over 1 minute to 2 minutes. If sequential or repeat examinations are required, allow at least 48 hours for clearance of the drug from the body before repeat administration; however, whenever possible, 5 days to 7 days is recommended.

If CT myelography is performed, delay imaging by several hours to reduce the degree of contrast. Table 1: Recommended Concentrations and Volumes of Iohexol Injection for Intrathecal Procedures in Adults Imaging Procedure Injection Type Concentration (mg Iodine/mL) Volume to Administer Lumbar Myelography Lumbar 180 * 10 mL to 17 mL 240 * 7 mL to 12.5 mL Thoracic Myelography Lumbar Cervical 240 * 6 mL to 12.5 mL 300 * 6 mL to 10 mL Cervical Myelography Lumbar 240 * 6 mL to 12.5 mL 300 * 6 mL to 10 mL C1-2 180 * 7 mL to 10 mL 240 * 6 mL to 12.5 mL 300 * 4 mL to 10 mL Total Columnar Myelography Lumbar 240 * 6 mL to 12.5 mL 300 * 6 mL to 10 mL CT Cisternography Lumbar 180 * 10 mL to 17 mL 240 * 7 mL to 12.5 mL * Use single-dose containers.

2.3Recommended Dosage for Intra-arterial Procedures in Adults The recommended doses for intra-arterial procedures in adults are shown in Table 2. Table 2: Recommended Concentrations and Volumes of Iohexol Injection for Intra-arterial Procedures in Adults Imaging Procedure Concentration (mg Iodine/mL) Volume to Administer per Single Injection for Selective Injection Sites Maximum Cumulative Total Dose Cardiac Ventriculography 350 * 40 mL (Range of 30 mL to 60 mL) may be combined with selective coronary arteriography 250 mL Aortography and Selective Visceral Arteriography 300 * Aorta (aortic arch, ascending aorta): 50 mL to 80 mL Abdominal aorta and its branches (celiac, mesenteric, hepatic and splenic arteries): 30 mL to 60 mL Renal arteries: 5 mL to 15 mL 290 mL 350 * 250 mL Aortic root and arch study when used alone 350 * 50 mL (Range of 20 mL to 75 mL) 250 mL Selective Coronary Arteriograp… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: Clear, colorless to pale yellow solution available in the following presentations: Dosage Form Concentration (mg of iodine/mL) Package Size Package Type Injection 300 50 mL, 75 mL and 100 mL Single-Dose Bottle 350 50 mL, 75 mL and 100 mL Injection: 300 mg iodine/mL and 350 mg iodine/mL in single-dose bottles. ( 3 )

⛔ Contraindications 122 words ▾

4 CONTRAINDICATIONS Iohexol for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. Hysterosalpingography during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia and when reproductive tract neoplasia is known or suspected.

( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.3 ) Acute Kidney Injury: Acute injury including renal failure can occur.

Minimize dose and maintain adequate hydration to minimize risk. ( 5.4 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.5 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.

( 5.9 )

5.1Risks Associated with Intrathecal Administration of Iohexol Injection 140 mg Iodine/mL and 350 mg Iodine/mL Use only the iodine concentrations and presentations recommended for intrathecal procedures [see Dosage and Administration (2.2 , 2.8) ]. Intrathecal administration of iohexol injection of a wrong iodine concentration, even if inadvertent, can cause death, convulsions, seizures, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, rhabdomyolysis, hyperthermia and brain edema.

5.2Risks Associated with Parenteral Administration of Iohexol Oral Solution Adverse reactions such as hemolysis may occur if iohexol oral solution is administered intravenously or intraarterially due to low osmolality [see Description (11) ] . Iohexol oral solution is for oral use only.

5.3Hypersensitivity Reactions Iohexol can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema and shock. Most severe reactions develop shortly after the start of the injection (within 1 to 3 minutes), but delayed reactions can also occur.

There is an increased risk in patients with a history of a previous reaction to contrast agent and known allergic disorders (i.e., bronchial asthma, drug, or food allergies) or other hypersensitivities. Premedication with antihistamines or corticosteroids does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to iohexol injection administration.

Monitor all patients for hypersensitivity reactions.

5.4Acute Kidney Injury Acute kidney injury, including renal failure, may occur after parenteral administration of iohexol injection. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma/paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent. Use the lowest necessary dose of iohexol in patients with renal impairment.

Adequately hydrate patients prior to and following parenteral administration of iohexol injection. Do not use laxatives, diuretics, or preparatory dehydration prior to iohexol injection administration.

5.5Cardiovascular Adverse Reactions Life-threatening or fatal cardiovascular reactions including hypotension, shock, cardiac arrest have occurred with the parenteral administration of iohexol injection. Most deaths occur during injection or five to ten minutes later, with cardiovascular disease as the main aggravating factor. Cardiac decompensation, serious arrhythmias and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.

Based on clinical literature, reported deaths from the administration of iodinated contrast agents range from 6.6 per million (0.00066%) to 1 in 10,000 (0.01%). Use the lowest necessary dose of iohexol in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Intrathecal Administration of Iohexol Injection 140 mg Iodine/mL and 350 mg Iodine/mL [see Warnings and Precautions (5.1) ] Risks Associated with Parenteral Administration of Iohexol Oral Solution [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Acute Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.5) ] Thromboembolic Events [see Warnings and Precautions (5.6) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.9) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence ≥ 1%) in adult patients Intrathecal: Headaches, pain including backache, neckache, stiffness and neuralgia, nausea, vomiting, dizziness.

Intra-arterial or intravenous: Pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea. Oral: Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache. Body Cavity: Pain, swelling, heat sensation.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Intrathecal Administration Adults Adverse reactions (≥ 1%) in 1,531 adult patients following intrathecal administration of iohexol injection in clinical trials are presented in Table 16. Table 16: Adverse Reactions (≥ 1%) in Adult Patients Following Intrathecal Administration of Iohexol Injection in Clinical Trials System Organ Class Adverse Reaction Incidence N = 1,531 Nervous system disorders Headaches 18% Musculoskeletal and connective tissue disorders Pain including backache, neckache, stiffness, neuralgia 8% Gastrointestinal disorders Nausea 6% Vomiting 3% Nervous System disorders Dizziness 2% Other adverse reactions (< 1%) were: Ear and labyrinth disorders : tinnitus, vertigo Eye disorders : photophobia General disorders and administration site conditions : sensation of heat Metabolism and nutrition disorders : loss of appetite Musculoskeletal and connective tissue disorders : feeling of heaviness Nervous system disorders : drowsiness, hypertonia, neuralgia, neurological changes, paresthesia, syncope Renal and urinary disorders : difficulty in micturition Skin and subcutaneous tissue disorders : sweating Vascular disorders : hypertension, hypotension Pediatric Patients The adverse reactions reported in pediatric patients following intrathecal administration of iohexol injection were generally similar to those reported in adults.

A total of 152 pediatric patients were administered iohexol injection 180 mg iodine/mL intrathecally by lumbar puncture for pediatric myelography in clinical trials. Adverse reactions (≥ 1%) are presented in Table 17. Table 17: Adverse Reactions (≥ 1%) in Pediatric Patients Following Intrathecal Administration of Iohexol Injection 180 mg iodine/mL by Lumbar Puncture for Myelography in Clinical Trials System Organ Class Adverse Reaction Incidence N = 152 Nervous system disorders Headache 9% Gastrointestinal disorders Vomiting 6% Musculoskeletal and connective tissue disorders Backache 1.3% Other adverse reactions (< 1%) were: Gastrointestinal disorders: stomachache General disorders and administration site conditions: fever Nervous system disorders : neurological changes Psychiatric disorders : visual hallucination Skin and subcuta… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 191 words ▾

7 DRUG INTERACTIONS

7.1Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, iohexol injection administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast.

Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable. Radioactive Iodine Iohexol may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post iohexol injection.

7.2Drug-Laboratory Test Interactions Protein-Bound Iodine Test Iodinated contrast agents, including iohexol, will temporarily increase protein-bound iodine in blood. Do not perform protein-bound iodine test for at least 16 days following administration of iohexol injection. However, thyroid function tests that do not depend on iodine estimation, e.g., T3 resin uptake or direct thyroxine assays, are not affected.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: A lactating woman may pump and discard breast milk for 10 hours after iohexol injection administration. ( 8.2 )

8.1Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts (see Data) .

In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1 g iodine/kg, 2 g iodine/kg, 4 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3 g iodine/kg, 1 g iodine/kg, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.

8.2Lactation Risk Summary Published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. There is no information on the effects of the drug on the breastfed infant or on milk production. Iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant.

Exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see Clinical Considerations). The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for iohexol and any potential adverse effects on the breastfed infant from iohexol or from the underlying maternal condition. Clinical Considerations Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small.

However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after iohexol injection administration to minimize drug exposure to a breastfed infant.

8.4Pediatric Use Intrathecal Use The safety and effectiveness of iohexol have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of iohexol is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. The safety and effectiveness of iohexol have not been established for intrathecal use in pediatric patients less than 2 weeks of age.

The safety and effectiveness of iohexol for CT cerebral ventriculography have not been established in pediatric patients. Intra-arterial or Intravenous Use Cardiac Ventriculography, Aortography and Pulmonary Angiography The safety and effectiveness of iohexol have been established i… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications (4) ]. There are no data with iohexol use in pregnant women to inform any drug-associated risks. Iohexol crosses the placenta and reaches fetal tissues in small amounts (see Data) .

In animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1 g iodine/kg, 2 g iodine/kg, 4 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3 g iodine/kg, 1 g iodine/kg, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Intrathecal Use The safety and effectiveness of iohexol have been established in pediatric patients aged 2 weeks and older for myelography and CT myelography (lumbar, thoracic, cervical, total columnar) and for CT cisternography. Use of iohexol is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. The safety and effectiveness of iohexol have not been established for intrathecal use in pediatric patients less than 2 weeks of age.

The safety and effectiveness of iohexol for CT cerebral ventriculography have not been established in pediatric patients. Intra-arterial or Intravenous Use Cardiac Ventriculography, Aortography and Pulmonary Angiography The safety and effectiveness of iohexol have been established in pediatric patients from birth to 17 years of age for cardiac ventriculography, aortography and pulmonary angiography. Use of iohexol is supported by controlled clinical studies in adults for cardiac ventriculography and aortography, in addition to controlled clinical studies in pediatric patients undergoing cardiac ventriculography, including aortography.

Excretory Urography The safety and effectiveness of iohexol have been established in pediatric patients from birth to 17 years of age for excretory urography. Use of iohexol is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth. CT of the Head and Body The safety and effectiveness of iohexol have been established in pediatric patients from birth to 17 years of age for CT imaging of the head and body.

Use of iohexol is supported by controlled clinical studies in adults for head and body CT, in addition to clinical studies in pediatric patients undergoing head CT and in 69 pediatric patients undergoing CT of the abdomen after oral administration of diluted iohexol plus intravenous administration of iohexol injection. Selective Coronary Arteriography, Cerebral and Peripheral Arteriography, Intra-arterial Digital Subtraction Angiography, Peripheral Venography and Intravenous Digital Subtraction Angiography The safety and effectiveness of iohexol have not been established in pediatric patients for selective coronary arteriography, cerebral or peripheral arteriography, intra-arterial digital subtraction angiography, peripheral venography and intravenous digital subtraction angiography.

Oral or Rectal Use Examination of the GI Tract The safety and effectiveness of iohexol have been established in pediatric patients, from birth to 17 years of age for examination of the GI tract. Use of iohexol is supported by controlled studies in adults for examination of the GI tract, in addition to clinical studies in pediatric patients undergoing examination of the GI tract. CT of the Abdomen and Pelvis in Conjunction with Intravenous Use The safety and effectiveness of iohexol for CT of the abdomen and pelvis have been established in pediatric patients from birth to 17 years of age.

Use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing CT of the abdomen. Intraarticular Use The safety and effectiveness of iohexol have not been established in pediatric patients for arthrography. Body Cavity Use Voiding Cystourethrography Iohexol is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (VCU).

Use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing VCU. ERCP, Herniography, and Hysterosalpingography The safety and effectiveness of iohexol have not been established in pediatric patients for ERCP, herniography, or hysterosalpingography. In general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [ s ee Adverse Reactions (6.1) ] .

Pe… [Excerpted — this section continues on DailyMed.]

🧓 Geriatric Use 105 words ▾

8.5Geriatric Use In clinical studies of iohexol for CT of the head and body, 52 (17%) of patients were 70 and over. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in safety and effectiveness between the elderly and younger patients.

Iohexol is substantially excreted by the kidney, and the risk of adverse reactions to iohexol may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

🆘 Overdosage 58 words ▾

10 OVERDOSAGE The adverse effects of overdosage in intra-arterial or intravenous administration are life-threatening and affect mainly the pulmonary and cardiovascular systems. The symptoms include: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma and cardiac arrest. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Iohexol can be dialyzed.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The iodine atoms in iohexol provide attenuation of X-rays in direct proportion to the concentration of iohexol. Since concentration changes over time, iohexol provides time-dependent image contrast which may assist in visualizing body structures.

12.2Pharmacodynamics Intrathecal Administration The initial concentration and volume of the contrast medium, in conjunction with patient manipulation and the volume of cerebrospinal fluid (CSF) into which the contrast medium is placed, will determine the extent of the contrast that can be achieved. Following intrathecal injection in conventional radiography, iohexol injection 180 mg iodine/mL, 240 mg iodine/mL and 300 mg iodine/mL will continue to provide contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream.

At approximately 1 hour following injection, contrast will no longer be sufficient for conventional myelography. After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours and in the basal cisterns in 3 hours to 4 hours. Intravenous or Intra-arterial Administration Following intravenous or intra-arterial administration of iohexol injection, the degree of contrast enhancement is directly related to the iodine concentration of an administered dose; peak iodine blood concentrations occur immediately (15 seconds to 120 seconds) following rapid intravenous injection.

The time to maximum contrast enhancement can vary, depending on the organ, from the time that peak blood iodine concentrations are reached to one hour after intravenous bolus administration. When a delay between peak blood iodine concentrations and peak contrast is present, it suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing agent within the lesion and outside the blood pool. Oral Administration Orally administered iohexol produces visualization of the gastrointestinal tract.

Less than 1% of orally administered iohexol is recovered in the urine, suggesting minimal amounts are absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruction. Intraarticular Administration Visualization of the joint spaces can be accomplished by direct injection of contrast medium.

For intraarticular cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Body Cavity Administration For most body cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.

12.3Pharmacokinetics Following the intravenous administration of iohexol (between 500 mg iodine/kg to 1,500 mg iodine/kg) to 16 adult subjects, apparent first-order terminal elimination half-life was 12.6 hours and total body clearance was 131 (98 to 165) mL/min. Clearance was not dose dependent. Absorption As evidenced by the amount recovered in urine, < 1% of orally administered iohexol is absorbed from the normal gastrointestinal tract.

This amount may increase in the presence of bowel perforation or bowel obstruction. Distribution In 16 adult subjects (receiving between 500 mg iodine/kg to 1,500 mg iodine/kg intravenous iohexol) the plasma volume of distribution was 165 (108 to 219) mL/kg. In five adult patients receiving 16 mL to 18 mL of iohexol (180 mg iodine/mL) by lumbar intrathecal injection the plasma volume of distribution was 559 (350 to 849) mL/kg.

Elimination Metabolism No significant metabolism, deiodination or biotransformation occ… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 38 words ▾

12.1Mechanism of Action The iodine atoms in iohexol provide attenuation of X-rays in direct proportion to the concentration of iohexol. Since concentration changes over time, iohexol provides time-dependent image contrast which may assist in visualizing body structures.

📦 How Supplied / Storage and Handling 181 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Iohexol Injection, USP is clear, colorless to pale yellow solution available in the following presentations: Dosage Form Concentration (mg iodine/mL) Package Size Package Type & Material Sale Unit NDC Injection 300 50 mL Single-Dose Polymer Bottles Carton of 10 80830-2466-2 75 mL Single-Dose Polymer Bottles Carton of 10 80830-2467-2 100 mL Single-Dose Polymer Bottles Carton of 10 80830-2468-2 350 50 mL Single-Dose Polymer Bottles Carton of 10 80830-2471-2 75 mL Single-Dose Polymer Bottles Carton of 10 80830-2472-2 100 mL Single-Dose Polymer Bottles Carton of 10 80830-2473-2 The container closure system components (bottle, stopper and cap) of iohexol injection are not made with natural rubber latex.

Storage and Handling Iohexol Injection: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. May be stored in a contrast media warmer for up to one month, not to exceed 37°C (98.6°F). Protect from light.

Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.

📋 Description ~1 min read ▾

11 DESCRIPTION Iohexol, USP is a nonionic radiographic contrast agent available as: Iohexol injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular and body cavity use. The chemical name of iohexol, USP is N,N’ -Bis(2,3-dihydroxypropyl)-5-[ N -(2,3-dihydroxypropyl) acetamido]-2,4,6-triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula: Iohexol Injection, USP is a sterile, pyrogen-free, clear, colorless to pale yellow solution available in following concentrations of iodine: Iohexol Injection USP, 300 mg iodine/mL: Each mL contains 647 mg iohexol, USP (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium, USP; 1.21 mg tromethamine, USP and water for injection.

Iohexol Injection USP, 350 mg iodine/mL: Each mL contains 755 mg iohexol, USP (providing 350 mg organically bound iodine) and the following inactive ingredients: 0.1 mg edetate calcium disodium, USP; 1.21 mg tromethamine, USP and water for injection. The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. Iohexol injection contain no preservatives and no ingredient made from a gluten-containing grain (wheat, barley, or rye).

Iohexol injection have the following physical properties: Table 21: Physicochemical Properties of Iohexol Injection Dosage Form Concentration (mg iodine/mL) Osmolality * (mOsmol/kg water) Absolute Viscosity (cP) Specific Gravity 20°C 37°C 37°C Injection 300 659 11.48 6.05 1.344 350 774 21.48 12.16 1.4054 * By Freezing Point Depression Osmometer. Iohexol injection has osmolalities from approximately 2.4 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic.

1

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after iohexol injection administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions (5.3) ]. Advise patients to inform their physician if they develop a rash after receiving iohexol injection [see Warnings and Precautions (5.12) ].

Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of contrast-induced acute kidney injury [see Warnings and Precautions (5.4) ] . Extravasation If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms [see Warnings and Precautions (5.7) ]. Lactation Advise a lactating woman that interruption of breastfeeding is not necessary.

However, to avoid any exposure, a lactating woman may consider pumping and discarding breast milk for 10 hours after iohexol injection administration [see Use in Specific Populations (8.2) ]. Thyroid Dysfunction Advise parents/caregivers about the risk of developing thyroid dysfunction after iohexol injection administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions (5.9) ].

Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

06-2026-01

🧬 Pharmacokinetics 188 words ▾

12.3Pharmacokinetics Following the intravenous administration of iohexol (between 500 mg iodine/kg to 1,500 mg iodine/kg) to 16 adult subjects, apparent first-order terminal elimination half-life was 12.6 hours and total body clearance was 131 (98 to 165) mL/min. Clearance was not dose dependent. Absorption As evidenced by the amount recovered in urine, < 1% of orally administered iohexol is absorbed from the normal gastrointestinal tract.

This amount may increase in the presence of bowel perforation or bowel obstruction. Distribution In 16 adult subjects (receiving between 500 mg iodine/kg to 1,500 mg iodine/kg intravenous iohexol) the plasma volume of distribution was 165 (108 to 219) mL/kg. In five adult patients receiving 16 mL to 18 mL of iohexol (180 mg iodine/mL) by lumbar intrathecal injection the plasma volume of distribution was 559 (350 to 849) mL/kg.

Elimination Metabolism No significant metabolism, deiodination or biotransformation occurs. Excretion Following intravenous, intra-arterial or intrathecal administration, iohexol is excreted unchanged by glomerular filtration. Approximately 90% of the intravenously injected iohexol dose is excreted within the first 24 hours.

Following intravenous or intraarterial administration, peak urine concentration occurs in the first hour after injection.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Intrathecal Administration The initial concentration and volume of the contrast medium, in conjunction with patient manipulation and the volume of cerebrospinal fluid (CSF) into which the contrast medium is placed, will determine the extent of the contrast that can be achieved. Following intrathecal injection in conventional radiography, iohexol injection 180 mg iodine/mL, 240 mg iodine/mL and 300 mg iodine/mL will continue to provide contrast for at least 30 minutes. Slow diffusion of iohexol takes place throughout the CSF with subsequent absorption into the bloodstream.

At approximately 1 hour following injection, contrast will no longer be sufficient for conventional myelography. After administration into the lumbar subarachnoid space, computerized tomography shows the presence of contrast medium in the thoracic region in about 1 hour, in the cervical region in about 2 hours and in the basal cisterns in 3 hours to 4 hours. Intravenous or Intra-arterial Administration Following intravenous or intra-arterial administration of iohexol injection, the degree of contrast enhancement is directly related to the iodine concentration of an administered dose; peak iodine blood concentrations occur immediately (15 seconds to 120 seconds) following rapid intravenous injection.

The time to maximum contrast enhancement can vary, depending on the organ, from the time that peak blood iodine concentrations are reached to one hour after intravenous bolus administration. When a delay between peak blood iodine concentrations and peak contrast is present, it suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine containing agent within the lesion and outside the blood pool. Oral Administration Orally administered iohexol produces visualization of the gastrointestinal tract.

Less than 1% of orally administered iohexol is recovered in the urine, suggesting minimal amounts are absorbed from the normal gastrointestinal tract. This amount may increase in the presence of bowel perforation or bowel obstruction. Intraarticular Administration Visualization of the joint spaces can be accomplished by direct injection of contrast medium.

For intraarticular cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Body Cavity Administration For most body cavities, the injected iohexol is absorbed into the surrounding tissue and subsequently absorbed into systemic circulation. Examinations of the uterus (hysterosalpingography) and bladder (voiding cystourethrography) involve the almost immediate drainage of contrast medium from the cavity upon conclusion of the radiographic procedure.

🔬 Clinical Studies 163 words ▾

14 CLINICAL STUDIES The safety and effectiveness of iohexol for CT of the head were evaluated in three clinical studies. Each study also used an ionic high-osmolar iodinated contrast agent as a comparator. A total of 280 patients were randomized to administration of either iohexol (n = 142) or the comparator (n = 138).

Iohexol patients had a mean age of 52 years (range 16 to 85), 41% were women and were administered a mean of 692 mg iodine/kg (range 337 mg iodine/kg to 1,250 mg iodine/kg) by intravenous injection with iohexol 240 mg iodine/mL (1 study) or 300 mg iodine/mL (2 studies). Efficacy was determined from investigator ratings of quality of contrast enhancement (none, poor, good, or excellent; only scans rated as good or excellent were considered diagnostic). The percentage of iohexol-enhanced scans rated as good or excellent was 100% in the two studies using iohexol injection 300 mg iodine/mL and 79% in the third study using iohexol injection 240 mg iodine/mL.

🧪 Nonclinical Toxicology 70 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed with iohexol to evaluate carcinogenic potential. Iohexol was not genotoxic in a series of studies, including the Ames test, the mouse lymphoma TK locus forward mutation assay and a mouse micronucleus assay. Iohexol did not impair the fertility of male or female rats when repeatedly administered at intravenous dosages up to 4 g iodine/kg.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 67 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed with iohexol to evaluate carcinogenic potential. Iohexol was not genotoxic in a series of studies, including the Ames test, the mouse lymphoma TK locus forward mutation assay and a mouse micronucleus assay. Iohexol did not impair the fertility of male or female rats when repeatedly administered at intravenous dosages up to 4 g iodine/kg.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL NDC 80830-2466-1 Iohexol Injection USP, 300 mgI/mL 50 mL Bottle Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2466-2 Iohexol Injection USP, 300 mgI/mL Carton Label (10 x 50 mL Bottles) Rx only Amneal Pharmaceuticals LLC Amneal Pharmaceuticals LLC NDC 80830-2467-1 Iohexol Injection USP, 300 mgI/mL 75 mL Bottle Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2467-2 Iohexol Injection USP, 300 mgI/mL Carton Label (10 x 75 mL Bottles) Rx only Amneal Pharmaceuticals LLC NDC 80830-2468-1 Iohexol Injection USP, 300 mgI/mL 100 mL Bottle Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2468-2 Iohexol Injection USP, 300 mgI/mL Carton Label (10 x 100 mL Bottles) Rx only Amneal Pharmaceuticals LLC NDC 80830-2471-1 Iohexol Injection USP, 350 mgI/mL 50 mL Bottle Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2471-2 Iohexol Injection USP, 350 mgI/mL Carton Label (10 x 50 mL Bottles) Rx only Amneal Pharmaceuticals LLC NDC 80830-2472-1 Iohexol Injection USP, 350 mgI/mL 75 mL Bottle Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2472-2 Iohexol Injection USP, 350 mgI/mL Carton Label (10 x 75 mL Bottles) Rx only Amneal Pharmaceuticals LLC NDC 80830-2473-1 Iohexol Injection USP, 350 mgI/mL 100 mL Bottle Label Rx only Amneal Pharmaceuticals LLC NDC 80830-2473-2 Iohexol Injection USP, 350 mgI/mL Carton Label (10 x 100 mL Bottles) Rx only Amneal Pharmaceuticals LLC 1 1 1 2 2 LL 3 2 5 6 8 8

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) ✓ 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Amneal Pharmaceuticals Private Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals Private Limited 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.
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.
← 80830-2466-02 · Amneal 80830-2468-02 · Amneal →
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.