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E-Z-Disk barium sulfate 700 mg Tablet, 100-count — NDC 10361-0778-31 package photo

E-Z-Disk barium sulfate 700 mg Tablet, 100-count

by E-Z-EM, INC. · 100 TABLET in 1 BOTTLE, GLASS (10361-778-31)
NDC 10361-0778-31
🏷️ FDA NDC (as labeled) 10361-778-31 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 10361-778-31
Product NDC 10361-778
11-digit billing NDC 10361077831
NCPDP billing unit EA — each (per item)
UNII 25BB7EKE2E
Application # NDA219840
SPL Set ID c759668b-5cf1-b237-00c8-a5e4733b6f4c
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 2009-02-01
Route ORAL
Dosage form TABLET
Substance BARIUM SULFATE
GPI-14 94401010100325
GPI class E-Z-Disk
GCN Seq No 065948
GCN 28086
HICL code 001119
Ingredient (HICL) Barium Sulfate
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D0
Therapeutic class — intermediate (HIC2) Drugs Acting Primarily On The Gi Tract As A Whole
HIC3 code D0U
Therapeutic class — specific (HIC3) Gastrointestinal Radiopaque Diagnostics
AHFS code 36:68.00.00
AHFS class Roentgenography And Other Imaging Agents
FDB label name E-Z DISK 700 MG TABLET
FDB brand name E-Z Disk
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 10361-778-31 — 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 → 10361-0778-31. 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

LabelerE-Z-EM, INC.
Application holderBRACCO DIAGNOSTICS INC
FDA applicationNDA219840 (NDA)
Labeler code10361
First marketedFeb 2009
Product typeHuman Prescription Drug
Portfolio2 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 E-Z DISK 700 MG TABLET Ingredient Barium Sulfate
📗 Our plain-language guide HelloPharmacist
  • Barium sulfate blocks X-rays, so when you drink it, it coats the inside of your esophagus, stomach, and intestines and makes them light up clearly on the scan or X-ray image. Witho...
  • Why do I have to drink barium before my scan? What does it actually do?
  • Your body doesn't absorb barium sulfate — it passes straight through your digestive tract and comes out in your stool, usually within a day or two. You may notice your stool looks...
  • Will it stay in my body? Is it safe to swallow?
📖 Read our full Barium Sulfate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
Imprint778;EZEM
Size13 mm
ScoringNot scored
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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.
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
E-Z-Disk 700 mgthis 10361-0778-31 E-Z-EM, 100 tablets — — 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

🏛️
2009
On the market since
Feb 2009
📍
2026
Currently FDA-listed
17 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
10361-0778-31 You're viewing this 100 TABLET in 1 BOTTLE, GLASS (10361-778-31) 2009-02-01 Active

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 10361-778-31, 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: 10361-0778-31, written without dashes as 10361077831. 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 10361-0778-31, the first segment (10361) is the labeler code FDA assigned to E-Z-EM, INC.; the middle segment (0778) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) 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 E-Z-EM, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
E-Z-EM, 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.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 49 words ▾

1 INDICATIONS AND USAGE E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older. E-Z-DISK is a radiographic contrast agent indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older. ( 1 )

⏱️ Dosage and Administration 122 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of E-Z-DISK in adults and pediatric patients aged 12 years and older is one 700 mg tablet orally during imaging. Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet.

Advise patients to hydrate following the E-Z-DISK imaging procedure [see Warnings and Precautions ( 5.3 )] . E-Z-DISK is formulated to disintegrate within the gastrointestinal (GI) tract. In the event of prolonged retention, consider implementing appropriate interventions.

The recommended dose is one 700 mg tablet orally during imaging. Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet.

( 2 )

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 700 mg of barium sulfate as a white to lightly colored, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter, flat-sided disk with EZEM inscribed on one side and 778 on the other side. Tablets: 700 mg of barium sulfate ( 3 )

⛔ Contraindications 168 words ▾

4 CONTRAINDICATIONS E-Z-DISK is contraindicated in patients with: Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Warnings and Precautions ( 5.1 )] Known, suspected, or high risk of perforation of the GI tract such as patients with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, recent GI surgery or biopsy, acute GI injury, or recent radiotherapy to the pelvis [see Warnings and Precautions ( 5.2 )] Known obstruction of the GI tract [see Warnings and Precautions ( 5.3 )] High risk of aspiration such as patients with known or suspected tracheoesophageal fistula or obtundation [see Warnings and Precautions ( 5.4 )] Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK ( 4 ) Known or suspected perforation of the gastrointestinal (GI) tract or conditions associated with high risk of GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of aspiration ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Have emergency equipment and trained personnel immediately available during the procedure. ( 5.1 ) Intra-abdominal Barium Leakage: Barium leakage may occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis, diverticulitis, and severe stenosis or obstructing lesions of the GI tract and has been associated with peritonitis and granuloma formation. ( 5.2 ) Baroliths and Bowel Obstruction: Maintain adequate hydration following a barium sulfate procedure and monitor patients at risk for delayed GI transit for development of signs and symptoms of bowel obstruction.

( 5.3 ) Aspiration Pneumonitis: Patients with a history of food aspiration or compromised swallowing mechanism may be at high risk. ( 5.4 )

5.1Hypersensitivity Reactions E-Z-DISK may induce serious hypersensitivity reactions with manifestations including hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, food allergies, or a reaction to a contrast agent may increase the risk for hypersensitivity reactions. E-Z-DISK is contraindicated in patients with known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Contraindications ( 4 )].

Have emergency equipment and trained personnel immediately available during the procedure.

5.2Intra-abdominal Barium Leakage Barium leakage from the GI tract has been associated with peritonitis and granuloma formation. Barium sulfate from orally administered E-Z-DISK may leak in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with severe stenosis of the GI tract, especially if it is distal to the stomach. E-Z-DISK is contraindicated in patients with known, suspected, or high risk of perforation of the GI tract [see Contraindications ( 4 )] .

5.3Baroliths and Bowel Obstruction Barium sulfate from orally administered E-Z-DISK may accumulate in the GI tract, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, or perforation. Patients with the following are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, low residue diet, medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and advanced age .

E-Z-DISK is contraindicated in patients with known obstruction of the GI tract [see Contraindications ( 4 )]. To reduce the risk of delayed GI transit and obstruction, maintain adequate hydration after the E-Z-DISK procedure. Monitor patients at risk for delayed gastrointestinal transit for development of signs and symptoms of bowel obstruction.

5.4Aspiration Pneumonitis Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. E-Z-DISK is contraindicated in patients with high risk of aspiration such as known or suspected tracheoesophageal fistula or obtundation [see Contraindications ( 4 )] .

5.5Systemic Embolization Barium sulfate from orally administered E-Z-DISK may intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications, which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia, and prolonged severe hypotension.

🤒 Adverse Reactions 183 words ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Intra-abdominal Barium Leakage [see Warnings and Precautions ( 5.2 )] Baroliths and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Aspiration Pneumonitis [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of E-Z-DISK or other barium sulfate products were identified in postmarketing reports or published clinical studies.

Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Cardiovascular disorders : Vasovagal and syncopal episodes Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping Respiratory disorders : Aspiration pneumonitis Adverse Reactions in Pediatric Patients No additional safety signals have been reported in pediatric patients aged 12 years and older.

Common adverse reactions include nausea, vomiting, diarrhea, and abdominal cramping. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

👥 Use in Specific Populations 144 words ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Barium sulfate is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to E-Z-DISK [see Clinical Pharmacology ( 12.3 )]

8.2Lactation Risk Summary Barium sulfate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to E-Z-DISK.

8.4Pediatric Use The safety and effectiveness of E-Z-DISK for use in radiographic evaluation of esophageal patency have been established in pediatric patients 12 years and older. Use of E-Z-DISK in this age group for this indication is supported by effectiveness established in studies of adults and pediatric safety data from other barium sulfate products [see Adverse Reactions ( 6 )] .

8.5Geriatric use Reported clinical experience has not identified differences between elderly and younger patients.

🤰 Pregnancy 32 words ▾

8.1Pregnancy Risk Summary Barium sulfate is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to E-Z-DISK [see Clinical Pharmacology ( 12.3 )]

🧒 Pediatric Use 62 words ▾

8.4Pediatric Use The safety and effectiveness of E-Z-DISK for use in radiographic evaluation of esophageal patency have been established in pediatric patients 12 years and older. Use of E-Z-DISK in this age group for this indication is supported by effectiveness established in studies of adults and pediatric safety data from other barium sulfate products [see Adverse Reactions ( 6 )] .

🧓 Geriatric Use 15 words ▾

8.5Geriatric use Reported clinical experience has not identified differences between elderly and younger patients.

🧬 Clinical Pharmacology 89 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action E-Z-DISK is formulated to pass through the esophagus into the stomach when the esophageal lumen is greater than 11.5 mm to 13.5 mm (0.45 inch to 0.53 inch) in diameter. Due to its high atomic number, barium is opaque to X-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2Pharmacodynamics Barium sulfate has no pharmacological effects.

12.3Pharmacokinetics Orally administered barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in insignificant amounts.

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action E-Z-DISK is formulated to pass through the esophagus into the stomach when the esophageal lumen is greater than 11.5 mm to 13.5 mm (0.45 inch to 0.53 inch) in diameter. Due to its high atomic number, barium is opaque to X-rays and therefore acts as a positive contrast agent for radiographic studies.

📦 How Supplied / Storage and Handling 80 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied E-Z-DISK (barium sulfate) tablets, 700 mg, are white to lightly colored, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter, flat-sided disks with EZEM inscribed on one side and 778 on the other side supplied in a glass bottle containing 100 tablets (NDC 10361-778-31). Storage and Handling Store at 20°C to 25°C (68°F to 77° F) [see USP controlled room temperature]. Store in original container and protect from moisture.

📋 Description 86 words ▾

11 DESCRIPTION E-Z-DISK (barium sulfate) tablet is a radiographic contrast agent for oral use. Barium sulfate is designated chemically as BaSO 4 with molecular weight of 233.4 g/mol, density of 4.5 g/cm 3 , and the following chemical structure: E-Z-DISK is a white to lightly colored, flat-sided disk, between 11.5 mm and 13.5 mm (0.45 inch and 0.53 inch) in diameter. Each tablet contains 700 mg barium sulfate and the following inactive ingredients: confectioner’s sugar, microcrystalline cellulose, corn starch, povidone, croscarmellose sodium, and magnesium stearate. formula

💬 Information for Patients 129 words ▾

17 PATIENT COUNSELING INFORMATION Administration Instructions Instruct patients to swallow E-Z-DISK as a whole tablet with the aid of one or two swallows of water (do not cut, crush, or chew) [see Dosage and Administration ( 2.2 )] . Hypersensitivity Reactions Advise patients to seek medical attention for any delayed onset of hypersensitivity such as rash, urticaria, or respiratory difficulty [see Warnings and Precautions ( 5.1 )]. Baroliths and Bowel Obstruction Advise patients to drink a sufficient amount of water to maintain adequate hydration following the E-Z-DISK procedure and to seek medical attention for signs and symptoms of bowel obstruction [see Warnings and Precautions ( 5.3 )] .

Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08540 by Confab Laboratories Inc. Saint Hubert (Quebec) Canada J3Y 3X3 rev.

08/25 301871-02

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 10357-0790-00 · NOVACYL 10361-0793-01 · E-Z-EM, →
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.