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Optiray 350 Ioversol 741 mg/mL Injection — NDC 00019-1333-91 package photo

Optiray 350 Ioversol 741 mg/mL Injection

by Liebel-Flarsheim Company LLC · 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91) / 75 mL in 1 SYRINGE, PLASTIC
NDC 00019-1333-91
🏷️ FDA NDC (as labeled) 0019-1333-91 billing pads the labeler segment with a zero
This package
Contains75 mL in 1 syringe, plastic Pack sizes21 compare ↓
Also comes in: 6 bottles 00019-1333-61 6 bottles 00019-1333-65 12 bottles 00019-1333-51 12 bottles 00019-1333-11 12 bottles 00019-1333-16 12 bottles 00019-1333-21 20 syringes 00019-1333-00 20 syringes 00019-1333-27 20 syringes 00019-1333-52 20 syringes 00019-1333-55 20 syringes 00019-1333-75 20 syringes 00019-1333-77 20 syringes 00019-1333-78 20 syringes 00019-1333-81 20 syringes 00019-1333-83 20 syringes 00019-1333-85 20 syringes 00019-1333-87 20 syringes 00019-1333-90 20 syringes 00019-1333-95 25 bottles 00019-1333-06
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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

🚨
Active recall for this product.
Class I · Jul 31, 2026 — Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. (Liebel-Flarsheim Company LLC) · FDA recall D-0773-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0019-1333-91
Product NDC 0019-1333
11-digit billing NDC 00019133391
NCPDP billing unit ML — per mL (volume)
UNII N3RIB7X24K
UPC 0300191332653, 0300191323651, 0300191333650
Application # NDA020923
SPL Set ID 6cb6ca5f-b249-49b0-a9eb-8aa583da7c74
Established class (EPC) Radiographic Contrast Agent
Mechanism of action X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-11-18
Route INTRA-ARTERIAL, INTRAVENOUS
Dosage form INJECTION
Substance IOVERSOL
GPI-14 94402055002074
GPI class Optiray 350
GCN Seq No 018746
GCN 21583
HICL code 004703
Ingredient (HICL) Ioversol
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 OPTIRAY 350 (350 MG/ML) SYRN
FDB brand name Optiray 350
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0019-1333-91 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00019-1333-91. 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.

🏭 Manufacturer & labeler

LabelerLiebel-Flarsheim Company LLC
Application holderLIEBEL-FLARSHEIM CO LLC
FDA applicationNDA020923 (NDA)
Labeler code00019
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio7 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name OPTIRAY 350 (350 MG/ML) SYRN Ingredient Ioversol
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.

🧪 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.

  • 0.2 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.
  • 3.6 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.

4 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.

💲 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 eachPer 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.
Try another pack size: 6 bottles 6 bottles 12 bottles 12 bottles 12 bottles 12 bottles 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 20 syringes 25 bottles
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Optiray 350 741 mg/mLthis 00019-1333-91 Liebel-Flarsheim 20 syringes — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00019-1333-51 12 BOTTLE, GLASS in 1 CARTON (0019-1333-51) / 250 mL in 1 BOTTLE, GLASS 2011-10-17 Active
00019-1333-61 6 BOTTLE, GLASS in 1 CARTON (0019-1333-61) / 500 mL in 1 BOTTLE, GLASS 2011-10-17 Active
00019-1333-00 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-06 25 BOTTLE, GLASS in 1 CARTON (0019-1333-06) / 50 mL in 1 BOTTLE, GLASS 2012-03-04 Active
00019-1333-11 12 BOTTLE, GLASS in 1 CARTON (0019-1333-11) / 100 mL in 1 BOTTLE, GLASS 2012-03-04 Active
00019-1333-16 12 BOTTLE, GLASS in 1 CARTON (0019-1333-16) / 150 mL in 1 BOTTLE, GLASS 2012-03-04 Active
00019-1333-21 12 BOTTLE, GLASS in 1 CARTON (0019-1333-21) / 200 mL in 1 BOTTLE, GLASS 2012-03-04 Active
00019-1333-27 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-27) / 125 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-52 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-52) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-55 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-55) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-75 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-75) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-77 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-77) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-78 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-78) / 50 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-81 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-81) / 125 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-83 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-83) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-85 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-85) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-87 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-87) / 125 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-90 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-90) / 100 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-91 You're viewing this 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-91) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-95 20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-95) / 75 mL in 1 SYRINGE, PLASTIC 2012-03-04 Active
00019-1333-65 6 BOTTLE, GLASS in 1 CARTON (0019-1333-65) / 500 mL in 1 BOTTLE, GLASS 2020-11-18 Active

Pack size FAQ

What quantity is in NDC 00019-1333-91?
NDC 00019-1333-91 is listed by the FDA — 20 syringe, plastic in 1 carton / 75 ml in 1 syringe, plastic.
What NDC number is used to bill for this package of Optiray 350 Ioversol 741 mg/mL Injection?
Bill NDC 00019-1333-91 — the 11-digit billing format is 00019133391. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 FDA registers it as 0019-1333-91, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00019-1333-91, written without dashes as 00019133391. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00019-1333-91, the first segment (00019) is the labeler code FDA assigned to Liebel-Flarsheim Company LLC; the middle segment (1333) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (91) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Liebel-Flarsheim Company LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 20 other package presentations of this same product, including 6 bottles (00019-1333-61), 6 bottles (00019-1333-65), 12 bottles (00019-1333-51). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Liebel-Flarsheim Company LLC 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 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 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 79 words ▾

WARNING: NOT FOR INTRATHECAL USE Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )]. WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning . Inadvertent intrathecal administration may cause death, convulsion, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1 )].

🎯 Indications and Usage 203 words ▾

1 INDICATIONS AND USAGE OPTIRAY is indicated for: OPTIRAY is a radiographic contrast agent indicated for the following: Intra-arterial Procedures ( 1.1 ) Adults: Cerebral Arteriography (320 mg iodine/mL) Peripheral Arteriography (320, 350 mg iodine/mL ) Visceral and Renal Arteriography, Aortography (320 mg iodine/mL) Coronary Arteriography and Left Ventriculography (320, 350 mg iodine/mL) Pediatric Patients: Angiocardiography (320, 350 mg iodine/mL) Intravenous Procedures ( 1.2 ) Adults: Computed tomography (CT) Imaging of Head and Body (320, 350 mg iodine/mL) Venography (320, 350 mg iodine/mL) Intravenous Excretory Urography (320, 350 mg iodine/mL) Intravenous Digital Subtraction Angiography (350 mg iodine/mL) Pediatric Patients: CT Imaging of the Head and Body, and Intravenous Excretory Urography (320mg iodine/mL).

1.1Intra-arterial In adults OPTIRAY 320: cerebral arteriography, peripheral arteriography, visceral and renal arteriography, aortography, coronary arteriography, and left ventriculography. OPTIRAY 350: peripheral arteriography, coronary arteriography, and left ventriculography. In pediatric patients OPTIRAY 320 and OPTIRAY 350: angiocardiography.

1.2Intra-venous In adults OPTIRAY 320: CT imaging of the head and body, venography, and intravenous excretory urography. OPTIRAY 350: CT imaging of the head and body, venography, intravenous excretory urography, and intravenous digital subtraction angiography (IV-DSA). In pediatric patients OPTIRAY 320: CT imaging of the head and body, and intravenous excretory urography.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The Pharmacy Bulk Package is not for direct infusion. Adjust the volume and concentration of OPTIRAY. Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel. Please see details in full Prescribing Information. ( 2 )

2.1Important Dosage and Administration Instructions OPTIRAY is for intravascular use only [see Boxed Warning, Contraindications (4), Warnings and Precautions ( 5.1 )] . Use sterile technique for all handling and administration of OPTIRAY. Inspect glass container prior to use for breakage or other damage and do not use damaged containers.

Warm OPTIRAY and administer at body or room temperature. Inspect OPTIRAY for particulate matter or discoloration before administration. Do not administer if OPTIRAY contains particulate matter or is discolored.

Do not mix OPTIRAY with other drugs, solutions or total parenteral nutrition mixtures. Use the lowest dose necessary to obtain adequate visualization. Adjust the volume and concentration of OPTIRAY.

Modify the dose accounting for factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Avoid extravasation when injecting OPTIRAY; especially in patients with severe arterial or venous disease [see Warnings and Precautions ( 5.6 )] . Hydrate patients before and after OPTIRAY administration [see Warnings and Precautions ( 5.3 )].

Directions for Proper Use of OPTIRAY Pharmacy Bulk Package The Pharmacy Bulk Package is not for direct infusion. Penetrate the container closure only one time, utilizing a suitable sterile transfer device or dispensing set which allows measured distribution of the contents. Transfer OPTIRAY from the Pharmacy Bulk Package only in a suitable work area, such as a laminar flow hood, utilizing aseptic technique.

Withdraw container contents immediately. However, should this not be possible, a maximum time of 4 hours from initial closure entry is permitted to complete fluid transfer operations. Temperature of container after the closure has been entered should not exceed 25°C (77°F).

2.2Intra-arterial Procedures in Adults Cerebral Arteriography Use OPTIRAY 320. The recommended dose for visualization of cerebral arteries is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose carotid or vertebral arteries 2 to 12 mL 200 mL aortic arch injection (four vessel study) 20 to 50 mL 200 mL Peripheral Arteriography Use OPTIRAY 320 or OPTIRAY 350. The recommended dose for visualization of peripheral arteries is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose aorta-iliac runoff 60 mL (range 20 to 90 mL) 250 mL common iliac, femoral 40 mL (range 10 to 50 mL) 250 mL subclavian, brachial 20 mL (range 15 to 30 mL) 250 mL Visceral and Renal Arteriography and Aortography Use OPTIRAY 320.

The recommended dose for visualization for the aorta and visceral arteries is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose aorta 45 mL (range 10 to 80 mL) 250 mL celiac 45 mL (range 12 to 60 mL) 250 mL superior mesenteric 45 mL (range 15 to 60 mL) 250 mL renal or inferior mesenteric 9 mL (range 6 to 15 mL) 250 mL Coronary Arteriography and Left Ventriculography Use OPTIRAY 320 or OPTIRAY 350. The recommended dose for visualization of the coronary arteries and left ventricle is shown below (may repeat as necessary): Diagnostic area Dose Maximum Cumulative Dose left coronary 8 mL (range 2 to 10 mL) 250 mL right coronary 6 mL (range 1 to 10 mL) 250 mL left ventricle 40 mL (range 30 to 50 mL) 250 mL

2.3Intravenous Procedures in Adults Computed Tomography Use OPTIRAY 320 or OPTIRAY 350 for head and body imaging. Head Imaging The recommended dosing is shown below: Scan immediately after completion o…

💊 Dosage Forms and Strengths 84 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: clear, colorless to pale yellow solutions containing no undissolved solids, available in the following strengths and multiple-dose containers: Imaging Product mg of ioversol per mL mg of organically bound iodine per mL Pharmacy Bulk Pack Presentation OPTIRAY 320 (Ioversol 68%) 678 320 Yes OPTIRAY 350 (Ioversol 74%) 741 350 Yes OPTIRAY Pharmacy Bulk Package is available in two strengths: Injection: 320 mg iodine/mL (ioversol 68%), 350 mg iodine/mL (ioversol 74%) in pharmacy bulk package bottles.

( 3 )

⛔ Contraindications 9 words ▾

4 CONTRAINDICATIONS Symptomatic hyperthyroidism. Symptomatic Hyperthyroidism ( 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. ( 5.2 ) Contrast Induced Acute Kidney Injury: Acute injury, including renal failure, can occur.

Minimize dose and maintain adequate hydration to minimize risk. ( 5.3 ) Cardiovascular Adverse Reactions: hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age: Individualize thyroid function monitoring based on risk factors such as prematurity.

( 5.8 )

5.1Risks Associated with Inadvertent Intrathecal Administration OPTIRAY is indicated for intravascular use only [see Dosage and Administration ( 2.1 )] . Inadvertent intrathecal administration can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

5.2Hypersensitivity Reactions OPTIRAY can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis and anaphylactic shock. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (e.g. within 1 to 3 minutes), but delayed reactions may occur.

There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, drug, or food allergies), and other hypersensitivities. Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions does not prevent serious life-threatening reactions, but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or prior hypersensitivity reactions to iodinated contrast agents.

Always have emergency resuscitation equipment and trained personnel available and monitor all patients for hypersensitivity reactions.

5.3Contrast Induced Acute Kidney Injury Acute kidney injury, including renal failure, may occur after OPTIRAY administration. 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 OPTIRAY in patients with renal impairment.

Adequately hydrate patients prior to and following OPTIRAY administration. Do not use laxatives, diuretics, or preparatory dehydration prior to OPTIRAY administration.

5.4Cardiovascular Adverse Reactions OPTIRAY increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, particularly when repetitive or large doses are administered. Life-threatening or fatal cardiovascular reactions have occurred with the use of OPTIRAY, including cardiac arrest, hypotensive collapse, and shock. Most deaths occur within 10 minutes of injection; with cardiovascular disease as the main underlying factor.

Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography. Based upon literature reports, deaths from the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Use the lowest necessary dose of OPTIRAY in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available.

Monitor all patients for severe cardiovascular reactions.

5.5Thromboembolic Events Angiocardiography Serious, fatal, thromboembolic events causing myocardial infarction and stroke c…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Contrast Induced Acute Kidney Injury [see Warnings and Precautions ( 5.3 )] Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] Thromboembolic Events [see Warnings and Precautions ( 5.5 )] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.8)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.10 ) The most common reaction is nausea, occurring at a rate of greater than 1 percent.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIEBEL-FLARSHEIM COMPANY LLC at 855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Adult Patients 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. The following table shows reactions based upon clinical trials with OPTIRAY (ioversol) in 4,187 patients. Adverse reactions are listed by organ system according to clinical importance.

More severe reactions are listed before others in a system regardless of incidence. The most common reaction is nausea, occurring at a rate of 1 percent. Cardiac disorders Cardiac arrest, myocardial infarction, arrhythmia, atrioventricular block complete, atrioventricular block, nodal rhythm, bradycardia, angina pectoris, palpitations Ear and labyrinth disorders Vertigo, tinnitus Eye disorders Vision blurred, periorbital edema, conjunctivitis Gastrointestinal disorders Vomiting, abdominal pain, dysphagia, dry mouth General disorders and administration site conditions Chest pain, pain, injection site pain, injection site hematoma, extravasation, pyrexia, swelling, asthenia, malaise, fatigue, chills Infections and infestations Rhinitis Injury, poisoning, and procedural complications Heart injury, vascular pseudoaneurysm Investigations Electrocardiogram ST segment depression, blood pressure decreased Metabolism and nutrition disorders Acidosis Musculoskeletal and connective tissue disorders Muscular weakness, muscle spasms, back pain Nervous system disorders Cerebral infarction, aphasia, tremor, dizziness, presyncope, headache, paraesthesia, dysgeusia Psychiatric disorders Hallucination, visual hallucination, disorientation, anxiety Renal and urinary disorders Urinary retention, renal pain, polyuria Respiratory, thoracic, and mediastinal disorders Laryngeal edema, hypoxia, pulmonary edema, dyspnea, hyperventilation, cough, sneezing, nasal congestion Skin and subcutaneous tissue disorders Urticaria, rash, pruritus, swelling face, hyperhidrosis, erythema Vascular disorders Hypertension, hypotension, arterial spasm, vasospasm, vasodilation, flushing Pediatric Patients In clinical trials involving 311 patients for pediatric angiocardiography, contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography; 6% of patients reported an adverse reactions, with the most common adverse reactions being nausea and fever.

Adverse reactions reported were similar in quality and frequency to the adverse events reported by adults.

6.2Postmarketing Experience The following adverse drug reactions have been reported during post-approval use of OPTIRAY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency or establish a casual relationship to drug exposure. Cardiac disorders: coronary artery spasm, cyanosis, arrhythmia (ventricular fibrillation, tachycardia, extrasystole), ECG abnormal.

Endocrine disorders: Hyperthyroidism, hypothyroidism. Eye disorders:…

🔄 Drug Interactions ~1 min read ▾

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, OPTIRAY administration in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents.

Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute only after renal function is stable. Radioactive Iodine Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I 131) and decrease therapeutic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6-8 weeks.

Oral Cholecystographic Contrast Agents Renal toxicity has been reported in patients with liver impairment who were given oral cholecystographic agents followed by intravascular contrast agents. Administration of OPTIRAY should be postponed in patients who have recently received a cholecystographic contrast agent.

7.2Drug/Laboratory Test Interactions Protein-Bound Iodine, Radioactive Iodine Determinations The results of protein bound iodine and radioactive iodine uptake studies, which depend on iodine estimation, will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast agent. However, thyroid function tests that do not depend on iodine estimations, e.g., T3 resin uptake and total or free thyroxine (T4) 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 8 hours after OPTIRAY administration. ( 8.2 )

8.1Pregnancy Risk Summary Postmarketing data with OPTIRAY use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes. Ioversol crosses the placenta and reaches fetal tissues in small amounts [see Data]. In animal reproduction studies, no adverse developmental effects were observed following daily intravenous administrations of ioversol to pregnant rats (from Gestation Day 7 to 17) and rabbits (Gestation Day 6 to 18) at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data Literature reports show that ioversol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Developmental toxicity studies were conducted with ioversol given intravenously at doses of 0, 0.2, 0.8, and 3.2 g iodine/kg/day from Gestation Day7 to 17 and 6 to 18, in rats and rabbits, respectively. No adverse effects on embryo-fetal development were observed in either species at the maximum dose tested (3.2 g iodine/kg/day).

Maternal toxicity was observed in rabbits at 0.8 and 3.2 g iodine/kg/day.

8.2Lactation Risk Summary There is no information about the presence of ioversol in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. However, iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OPTIRAY and any potential adverse effects on the breastfed infant from OPTIRAY 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 8 hours (approximately 5 elimination half-lives) after OPTIRAY administration in order to minimize drug exposure to a breast fed infant.

8.4Pediatric Use Safety and effectiveness in pediatric patients have been established for the use of OPTIRAY 350 and OPTIRAY 320 in angiocardiography; and for OPTIRAY 320 in contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. Use of OPTIRAY 350 and OPTIRAY 320 in these age groups is based on controlled clinical trials involving 159 patients for pediatric angiocardiography; contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

In general, the types of adverse reactions reported are similar to those of adults [see Adverse Reactions ( 6.1 )] . Safety and effectiveness of OPTIRAY 350 and OPTIRAY 320 have not been established in pediatric patients less than 1 month of age. Pediatric patients at higher risk of experiencing adverse reactions to OPTIRAY include patients with: asthma, sensitivity to medication and/or allergens, congestive heart failure, serum creatinine greater than 1.5 mg/dL, or age less than 12 months.

Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration in pediatric patients, including infants. Some patients were treated for hypothyroidism [See Adverse R…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Postmarketing data with OPTIRAY use in pregnant women are insufficient to determine if there is a risk of drug-associated adverse developmental outcomes. Ioversol crosses the placenta and reaches fetal tissues in small amounts [see Data]. In animal reproduction studies, no adverse developmental effects were observed following daily intravenous administrations of ioversol to pregnant rats (from Gestation Day 7 to 17) and rabbits (Gestation Day 6 to 18) at doses 0.35 and 0.71 times, respectively, the maximum recommended human dose.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Data Human Data Literature reports show that ioversol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. Animal Data Developmental toxicity studies were conducted with ioversol given intravenously at doses of 0, 0.2, 0.8, and 3.2 g iodine/kg/day from Gestation Day7 to 17 and 6 to 18, in rats and rabbits, respectively. No adverse effects on embryo-fetal development were observed in either species at the maximum dose tested (3.2 g iodine/kg/day).

Maternal toxicity was observed in rabbits at 0.8 and 3.2 g iodine/kg/day.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have been established for the use of OPTIRAY 350 and OPTIRAY 320 in angiocardiography; and for OPTIRAY 320 in contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. Use of OPTIRAY 350 and OPTIRAY 320 in these age groups is based on controlled clinical trials involving 159 patients for pediatric angiocardiography; contrast enhanced computed tomographic imaging of the head and body, and intravenous excretory urography.

In general, the types of adverse reactions reported are similar to those of adults [see Adverse Reactions ( 6.1 )] . Safety and effectiveness of OPTIRAY 350 and OPTIRAY 320 have not been established in pediatric patients less than 1 month of age. Pediatric patients at higher risk of experiencing adverse reactions to OPTIRAY include patients with: asthma, sensitivity to medication and/or allergens, congestive heart failure, serum creatinine greater than 1.5 mg/dL, or age less than 12 months.

Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration in pediatric patients, including infants. Some patients were treated for hypothyroidism [See Adverse Reactions ( 6.2 )] . Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates;some patients were treated for hypothyroidism.

After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warnings and Precautions ( 5.8 ) and Adverse Reactions ( 6.2 )].

🧓 Geriatric Use 72 words ▾

8.5Geriatric Use OPTIRAY is substantially excreted by the kidney, and the risk of adverse reactions to OPTIRAY may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, dose selection should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 49 words ▾

10 OVERDOSAGE The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. Treatment of an overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy. Ioversol does not bind to plasma or serum protein and is, therefore, dialyzable.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Ioversol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring within 5 to 15 minutes.

OPTIRAY enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes.

This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about 10 minutes; thereafter, the fall becomes exponential.

12.2Pharmacodynamics Following administration of OPTIRAY, the degree of enhancement is directly related to the iodine content in an administered dose. Peak iodine plasma levels occur immediately following rapid 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 medium within the lesion and outside the blood pool. For angiography, contrast enhancement is greatest immediately (15 seconds to 120 seconds) after rapid injection. Iodinated contrast agents may be visualized in the renal parenchyma within 30-60 seconds following rapid intravenous injection.

Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1-3 minutes, with optimum contrast occurring within 5-15 minutes.

12.3Pharmacokinetics Based on the blood clearance curves for 12 healthy volunteers (6 receiving 50 mL and 6 receiving 150 mL of OPTIRAY 320), the biological half-life was 1.5 hours for both doses. Distribution In an in vitro human plasma study, ioversol did not bind to protein. The volume of distribution in adults was

0.26L/kg body weight, consistent with distribution to the extracellular space. Elimination Metabolism Ioversol does not undergo significant metabolism, deiodination or biotransformation. Excretion Greater than 95% of the administered dose was excreted in urine within the first 24 hours, with the peak urine concentration occurring in the first two hours after administration.

🧬 Mechanism of Action 171 words ▾

12.1Mechanism of Action Intravascular injection of ioversol opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Ioversol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 1 to 3 minutes, with optimum contrast occurring within 5 to 15 minutes.

OPTIRAY enhances computed tomographic imaging through augmentation of radiographic efficiency. The degree of density enhancement is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid intravenous injection. Blood levels fall rapidly within 5 to 10 minutes and the vascular compartment half-life is approximately 20 minutes.

This can be accounted for by the dilution in the vascular and extravascular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about 10 minutes; thereafter, the fall becomes exponential.

📦 How Supplied / Storage and Handling 178 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied OPTIRAY is a clear, colorless to pale yellow, sterile, pyrogen-free, aqueous solution available in two strengths. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY is supplied in the following configurations: NDC Number OPTIRAY Pharmacy Bulk Package - 350 6x500 mL Pharmacy Bulk Packages 0019-1333-61 OPTIRAY Pharmacy Bulk Package - 320 6x500 mL Pharmacy Bulk Packages 0019-1323-61

16.2Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from strong daylight or direct exposure to the sun. Discard OPTIRAY containers, and their contents, if they are frozen or if crystallization occurs.

16.1How Supplied OPTIRAY is a clear, colorless to pale yellow, sterile, pyrogen-free, aqueous solution available in two strengths. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY is supplied in the following configurations: NDC Number OPTIRAY Pharmacy Bulk Package - 350 6x500 mL Pharmacy Bulk Packages 0019-1333-61 OPTIRAY Pharmacy Bulk Package - 320 6x500 mL Pharmacy Bulk Packages 0019-1323-61

📦 Storage and Handling 39 words ▾

16.2Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from strong daylight or direct exposure to the sun. Discard OPTIRAY containers, and their contents, if they are frozen or if crystallization occurs.

📋 Description ~1 min read ▾

11 DESCRIPTION

11.1Chemical Characteristics OPTIRAY (ioversol injection) is a non-ionic radiographic contrast agent. OPTIRAY formulations are sterile, nonpyrogenic, aqueous solutions intended for intravascular use. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a suitable transfer device.

Ioversol is designated chemically as N,N' -Bis (2,3-dihydroxypropyl)-5-[ N -(2-hydroxyethyl) -glycolamido] -2,4,6-triiodoisophthalamide. The molecular weight of ioversol is 807.11 and the organically bound iodine content is 47.2%. The structural formula of ioversol is as follows: OPTIRAY Pharmacy Bulk Package is available in two strengths: OPTIRAY 320 (ioversol injection 68%): Each mL contains 320 mg organically bound iodine, 678 mg of ioversol, 3.6 mg tromethamine, 0.2 mg edetate calcium disodium.

OPTIRAY 350 (ioversol injection 74%): Each mL contains 350 mg organically bound iodine, 741 mg ioversol, 3.6 mg tromethamine, 0.2 mg edetate calcium disodium. The pH of the OPTIRAY formulations has been adjusted to 6.0 to 7.4 with hydrochloric acid or sodium hydroxide. All solutions are sterilized by autoclaving and contain no preservatives.

Ioversol does not dissociate in solution. chem-structure

11.2Physical Characteristics Some physical and chemical properties of these formulations are listed below: OPTIRAY 320 OPTIRAY 350 Ioversol content (mg/mL) 678 741 Iodine content (mg l/mL) 320 350 Osmolality (mOsm/kg water) 702 792 Viscosity (cps) at 25°C 9.9 14.3 at 37°C 5.8

9.0Specific Gravity at 37°C 1.371 1.405 The OPTIRAY formulations are clear, colorless to pale yellow solutions containing no undissolved solids. Crystallization does not occur at room temperature. OPTIRAY solutions have osmolalities 2.3 to 2.8 times that of plasma (285 mOsm/kg water) as shown in the above table and are hypertonic under conditions of use.

💬 Information for Patients 185 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after OPTIRAY administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek medical attention for signs or symptoms experienced after discharge [see Warnings and Precautions ( 5.2 )] . Advise patients to inform their physician if they develop a rash after receiving OPTIRAY [see Warnings and Precautions ( 5.11 )] .

Contrast Induced Acute Kidney Injury Advise the patient concerning appropriate hydration to decrease the risk of contrast induced kidney injury [see Warnings and Precautions ( 5.3 )] . Extravasation If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms [see Warnings and Precautions ( 5.6 )] . Thyroid Dysfunction Advise parents/caregivers about the risk of developing thyroid dysfunction after OPTIRAY administration.

Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions ( 5.8 )]. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 13PB825 image description

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