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Iomeron Iomeprol Injection 816 mg/mL Injection, Solution — NDC 76381-0940-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Iomeron Iomeprol Injection 816 mg/mL Injection, Solution — NDC 76381-940-01 (Billing 76381-0940-01)

by BIPSO GmbH · 9 BOTTLE, GLASS in 1 BOX / 500 mL in 1 BOTTLE, GLASS

This is a package of Iomeron Iomeprol Injection 816 mg/mL Injection, Solution from BIPSO GmbH, marketed since Jul 2022 and currently FDA-listed, this package's marketing is listed to end Mar 2027. It is the main listing for this product, which comes in 3 package sizes.

NDC 76381-0940-01
🏷️ FDA NDC (as labeled) 76381-940-01 billing pads the product segment with a zero
This package
Contains500 mL in 1 bottle, glass Pack sizes3 compare ↓
Main listing for product 76381-940 · Also comes in: 6 bottles 76381-940-06 9 bottles 76381-940-03
Rx only 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

NDC database record

One package, one record: these facts belong to NDC 76381-940-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
76381 labeler · 940 product · 01 package
Package marketed since
Jul 1, 2022
Package marketing ended
Mar 1, 2027
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7638194001 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76381-940-01
Product NDC 76381-940
11-digit billing NDC 76381094001
UNII 17E17JBP8L
SPL Set ID 30a993a8-9afb-42c2-a4b2-72a6b361d43c
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 On market
FDA listing status Listed (active directory)
Marketing start 2022-07-01
Route INTRAVASCULAR
Dosage form INJECTION, SOLUTION
Substance IOMEPROL
Why two NDCs? The FDA registers this code as 76381-940-01 — a 5-3-2 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 product segment → 76381-0940-01. 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

📗 Our plain-language guide HelloPharmacist
  • It is a contrast dye that makes your blood vessels and organs show up clearly on X-ray or CT scans. It does not treat a condition. It helps your doctors see what is going on.
  • A trained professional injects it into an artery or a vein during your scan. The amount is chosen for your age, weight and the area being imaged. You should drink fluids as directe...
  • The most common are feeling hot, headache, nausea, chest pain, back pain and vomiting. Tell staff right away if you have trouble breathing, swelling, or severe dizziness. Report ra...
  • It can be. Metformin may need to be stopped at or before the scan, especially with reduced kidney function, liver problems, alcoholism, heart failure, or an artery injection. Your...
📖 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
76381-0940-01 You're viewing this Main listing 9 BOTTLE, GLASS in 1 BOX / 500 mL in 1 BOTTLE, GLASS 2022-07-01 Mar 1, 2027 Active
76381-0940-03 76381-940-03 9 BOTTLE, GLASS in 1 BOX / 500 mL in 1 BOTTLE, GLASS 2022-07-01 — Discontinued by firm
76381-0940-06 76381-940-06 6 BOTTLE, GLASS in 1 BOX / 500 mL in 1 BOTTLE, GLASS 2022-07-01 Feb 1, 2027 Active

Pack size FAQ

What quantity is in this package?
This package 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?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Iomeron 816 mg/mLthis 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/mL 00270-9400-01 BRACCO 9 bottles — — FDA listed —
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.

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.

🧪 Avoiding an ingredient? See Iomeprol Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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.

Manufacturer & labeler

LabelerBIPSO GmbH
Labeler code76381
First marketedJul 2022
Product typeHuman Prescription Drug
Portfolio7 products on file

More NDCs from BIPSO GmbH labeler code 76381

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.
💬 Medication Guide 📄 Package Label / Principal Display Panel
💬 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… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 28 words ▾

Iomeron 250 100ml box Iomeron 300 100ml label Iomeron 300 500ml label Iomeron 350 200ml box Iomeron 350 500ml label Iomeron 400 200ml label Iomeron 400 500ml label

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 Marketed without an FDA application

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.
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 BIPSO GmbH. 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 2 other package presentations of this same product, including 6 bottles (76381-0940-06), 9 bottles (76381-0940-03). 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?
BIPSO GmbH 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.
← 76381-0935-06 · BIPSO 76385-0100-01 · Unichem →
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.