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Iomeron Iomeprol Injection 816 mg/mL Injection, Solution — NDC 00270-9400-03 package photo

Iomeron Iomeprol Injection 816 mg/mL Injection, Solution

by BRACCO DIAGNOSTICS INC · 9 BOTTLE, GLASS in 1 BOX (0270-9400-03) / 500 mL in 1 BOTTLE, GLASS
NDC 00270-9400-03
🏷️ FDA NDC (as labeled) 0270-9400-03 billing pads the labeler segment with a zero
This package
Contains500 mL in 1 bottle, glass Pack sizes3 compare ↓
Also comes in: 6 bottles 00270-9400-06 9 bottles 00270-9400-01
Rx only Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0270-9400-03
Product NDC 0270-9400
11-digit billing NDC 00270940003
UNII 17E17JBP8L
SPL Set ID 4b31d479-fd1c-5ed7-5bdf-dfd34fe08d98
Established class (EPC) Radiographic Contrast Agent
Mechanism of action X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2022-07-01
Route INTRAVASCULAR
Dosage form INJECTION, SOLUTION
Substance IOMEPROL
Why two NDCs? The FDA registers this code as 0270-9400-03 — 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 → 00270-9400-03. 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

LabelerBRACCO DIAGNOSTICS INC
Labeler code00270
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio30 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

📗 Our plain-language guide HelloPharmacist
  • IOMERVU is a contrast dye — a liquid containing iodine — that gets injected into your vein or artery just before or during your imaging procedure. It makes blood vessels and organs...
  • What exactly is IOMERVU and why do I need it for my scan?
  • It's very common to feel a warm or flushing sensation when the dye goes in — that's the most frequently reported feeling, and it passes quickly. Some people also get a mild headach...
  • Will I feel anything when the dye is injected?
📖 Read our full Iomeprol Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 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.

  • 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 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.

3 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 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.
Try another pack size: 6 bottles 9 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
Iomeron 816 mg/mL 76381-0940-01 BIPSO 9 bottles — — FDA listed —
Iomeron 816 mg/mL 00270-7400-10 BRACCO 10 bottles — — Discontinued —
Iomeron 816 mg/mL 76381-0740-10 BIPSO 10 bottles — — Discontinued —
Iomeron 816 mg/mLthis 00270-9400-03 BRACCO 9 bottles — — Discontinued —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Iomeron (this brand).

Top reported reactions

Rash Maculo-papular218
Drug Reaction With Eosinophilia And Systemic Symptoms167
Acute Kidney Injury136
Eosinophilia110
Toxic Skin Eruption97
Acute Generalised Exanthematous Pustulosis92
Pruritus80

Age at onset

Neonate1
Adolescent3
Adult91
Elderly111

Reporter sex

1,328 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization823
Life-threatening174
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 302 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00270-9400-01 9 BOTTLE, GLASS in 1 BOX (0270-9400-01) / 500 mL in 1 BOTTLE, GLASS 2022-07-01 Active
00270-9400-03 You're viewing this 9 BOTTLE, GLASS in 1 BOX (0270-9400-03) / 500 mL in 1 BOTTLE, GLASS 2022-07-01 Discontinued by firm
00270-9400-06 6 BOTTLE, GLASS in 1 BOX (0270-9400-06) / 500 mL in 1 BOTTLE, GLASS 2022-07-01 Active

Pack size FAQ

What quantity is in NDC 00270-9400-03?
NDC 00270-9400-03 is listed by the FDA — 9 bottle, glass in 1 box / 500 ml in 1 bottle, glass.
What NDC number is used to bill for this package of Iomeron Iomeprol Injection 816 mg/mL Injection, Solution?
Bill NDC 00270-9400-03 — the 11-digit billing format is 00270940003. 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 Marketed without an FDA application No longer marketed (per FDA listing data)

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Drug For Use In Drug Shortage". Products approved under an application carry an NDA, ANDA, or BLA number.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0270-9400-03, 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: 00270-9400-03, written without dashes as 00270940003. 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 00270-9400-03, the first segment (00270) is the labeler code FDA assigned to BRACCO DIAGNOSTICS INC; the middle segment (9400) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 6 bottles (00270-9400-06), 9 bottles (00270-9400-01). 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?
BRACCO DIAGNOSTICS INC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
💬 Medication Guide
💬 Medication Guide ~3 min read ▾

1. NAME OF THE MEDICINAL PRODUCT Iomeron 250, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Contains 51.03% w/v of iomeprol equivalent to 25% iodine or 250mg iodine/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS

4.1T herapeutic indications X-ray contrast medium used for: venography cerebral arteriography digital subtraction angiography computed tomography enhancement urography cavernosography myelography

4.2Posology and method of administration * Repeat as necessary * * According to body size and age venography adults 10 - 100ml* max 250ml 10 - 50ml upper extremity 50 - 100 lower extremity cerebral arteriography adults 5 - 12ml* children 3 - 7ml or * * digital subtraction angiography Intra arterial visceral adults 2 - 20ml per artery* aorta 25-50ml* both 250ml max peripheral adults 5 - 10ml per artery* max 250ml intravenous adults 30 - 60ml* max 250ml computed tomography brain adults 50 - 150 children * * body adults 40 - 150ml max 250ml children * * urography adults 50 - 150ml intravenous neonates 3 - 4.8ml/kg babies 2.5 - 4ml/kg children 1 - 2.5ml/kg or * cavernosography adults 40 - 250ml myelography adults 12 - 18ml by lumbar injection In elderly patients the lowest effective dose should be used.

Unless otherwise instructed by the doctor, a normal diet may be maintained on the day of the examination. In myelography, lower doses may be used for lumbar or thoracic studies and higher doses for cervical or total columnar studies. Regardless of the nature of the myelographic study, Iomeron should be injected slowly over 1-2 minutes.

The X ray can be taken up to 60 minutes following injection. Post myelographic CT of the spinal column should be delayed for approximately four hours to allow dilution and clearance of excessive contrast.

4.3Contraindications Hypersensitivity to the active substance or any of the excipients. Intrathecal concomitant administration of corticosteroids with contrast media is contraindicated.

4.4Special warnings and special precautions for use In consideration of possible complications, the patient should be kept under observation for at least 30 minutes after the examination. Extreme caution during injection of contrast media is necessary to avoid extravasation. Hydration Patients must be well hydrated, and any relevant abnormalities of fluid or electrolyte balance should be corrected prior to and following contrast media injection.

Especially patients with diabetes mellitus, polyuria, oligouria, hyperuricaemia, infants, small children, and elderly patients, should not be exposed to dehydration. Also patients with severely compromised hepatic and renal impairment are more at risk. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, including congestive heart failure.

Rehydration prior to use of iomeprol is recommended in patients with sickle cell disease. Special population Hypersensitivity to iodinated contrast media, allergic predisposition A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution since, as with other contrast media, this product may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnoea, erythema, urticaria and hypotension. The benefits should clearly outweigh the risks in such patients and appropriate resuscitative measures should be immediately available.

The primary treatments are as follows: Effect Major Symptoms Primary Treatment Vasomotor effect warmth nausea/vomiting reassurance Cutaneous scattered hives severe urticaria H 1 -antihistamines H 2 -antihistamines Bronchospastic wheezing oxygen Beta-2-agonist inhalers Anaphylactoid angioedema oxygen reaction urticaria bronchospasm hypotension iv fluids adrenergics (iv epinephrine) Inhaled beta-2-adrenergics antihistamines (H 1 -and H 2 - blockers) corticosteroid…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00270-9350-06 · BRACCO 00273-0357-44 · Young →
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.