HomeNDC LookupIngredientsBarium Sulfate › 32909-0125-22
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Varibar Pudding Barium Sulfate 400 mg/mL Paste

by E-Z-EM Canada Inc · 1 TUBE in 1 BOX (32909-125-22) / 230 mL in 1 TUBE
NDC 32909-0125-22
🏷️ FDA NDC (as labeled) 32909-125-22 billing pads the product segment with a zero
This package
Contains230 mL in 1 tube Pack sizes2 compare ↓
Also comes in: 24 tubes 32909-0125-54
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 →

🆔 Identity & classification

FDA NDC (as labeled) 32909-125-22
Product NDC 32909-125
11-digit billing NDC 32909012522
NCPDP billing unit ML — per mL (volume)
UNII 25BB7EKE2E
Application # NDA208844
SPL Set ID 553285e2-d0e9-8b7b-4766-a0a6b9496f87
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 2016-10-14
Route ORAL
Dosage form PASTE
Substance BARIUM SULFATE
GPI-14 94401010104465
GPI class Varibar Pudding
GCN Seq No 065208
GCN 23664
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 VARIBAR PUDDING 40% PASTE
FDB brand name Varibar Pudding
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 32909-125-22 — 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 → 32909-0125-22. 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 Canada Inc
Application holderBRACCO DIAGNOSTICS INC
FDA applicationNDA208844 (NDA)
Labeler code32909
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio16 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 VARIBAR PUDDING 40% PASTE 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.

🧪 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII MCU2324216
    A silicone-based oil that reduces foaming and helps ingredients mix evenly. It's used as an antifoaming agent and lubricant in tablets, capsules, and liquid formulations.
  • UNII 2Y53S6ATLU
    Dimethicone 350 is a silicone-based oil. It works as a lubricant and anti-foaming agent to help the medicine flow smoothly during manufacturing and reduce unwanted bubbles in the final product.
  • UNII YC9ST449YJ
    Ethyl vanillin is a synthetic vanilla flavoring compound. It's added to medicines to mask bitter or unpleasant tastes, making them easier to take.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

15 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 DailyMedingredient 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 gPer 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: 24 tubes
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
Varibar Pudding 400 mg/mLthis 32909-0125-22 E-Z-EM 1 tube 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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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 Varibar Pudding (this brand).

Top reported reactions

Renal Failure18
Acute Kidney Injury17
Urticaria16
Chronic Kidney Disease15
Diarrhoea15
Rash14
Dyspnoea13

Age at onset

Infant1
Adult17
Elderly14

Reporter sex

259 reports
Male · 41%
Female · 56%
Unknown · 3%

Serious outcomes

Hospitalization114
Death31
Life-threatening25
Disabling17
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 20 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
32909-0125-22 You're viewing this 1 TUBE in 1 BOX (32909-125-22) / 230 mL in 1 TUBE 2016-10-14 Active
32909-0125-54 24 TUBE in 1 CASE (32909-125-54) / 30 mL in 1 TUBE 2024-11-01 Active

Pack size FAQ

What quantity is in NDC 32909-0125-22?
NDC 32909-0125-22 is listed by the FDA — 1 tube in 1 box / 230 ml in 1 tube.
What NDC number is used to bill for this package of Varibar Pudding Barium Sulfate 400 mg/mL Paste?
Bill NDC 32909-0125-22 — the 11-digit billing format is 32909012522. 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 — Not published for this NDC No photo available yet for this listing.
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 32909-125-22, 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: 32909-0125-22, written without dashes as 32909012522. 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 32909-0125-22, the first segment (32909) is the labeler code FDA assigned to E-Z-EM Canada Inc; the middle segment (0125) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) 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 Canada Inc. 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 1 other package presentation of this same product, including 24 tubes (32909-0125-54). 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?
E-Z-EM Canada 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 71 words

1 INDICATIONS AND USAGE VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older ( 1 )

⏱️ Dosage and Administration 162 words

2 DOSAGE AND ADMINISTRATION For oral use only – administered by syringe or spoon ( 2.1 ) Adults: 5 mL Pediatric patients: 1-3 mL Multiple doses may be administered Maximum cumulative dose : 30 mL

2.1Recommended Dosing The recommended oral dose of VARIBAR PUDDING delivered by oral syringe or spoon: Adults 5 mL Pediatric patients 1-3 mL During a single modified barium swallow examination, multiple doses of VARIBAR PUDDING may be administered as appropriate, to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 30 mL oral. Once opened, write the discard after date on the immediate container label.

Discard any unused product after 21 days.

2.2Important Administration Instructions Advise patients to hydrate following the barium sulfate procedure. Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.

💊 Dosage Forms and Strengths 60 words

3 DOSAGE FORMS AND STRENGTHS Oral Paste: an off-white to lightly colored ready-to-use paste with a vanilla aroma for oral administration supplied in multiple-dose polyethylene tubes containing either 30 mL or 230 mL of barium sulfate (40% w/v). Oral paste: barium sulfate (40% w/v) in a 30 mL or 230 mL multiple dose tube for oral administration ( 3 )

Contraindications 157 words

4 CONTRAINDICATIONS VARIBAR PUDDING is contraindicated in patients with: - known or suspected perforation of the gastrointestinal (GI) tract; - known obstruction of the GI tract; - high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis; - high risk for aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; - known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING.

VARIBAR PUDDING is contraindicated in patients with: Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Conditions associated with high risk for GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Patients with trachea-esophageal fistula ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING ( 4 )

⚠️ Warnings and Cautions ~3 min read

5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Emergency equipment and trained personnel should be immediately available ( 5.1 ) Intra-abdominal leakage: May occur with conditions which increase the risk for perforation such as – carcinomas, GI fistula, Inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, diverticulitis, or severe stenosis or obstructing lesions of the GI tract ( 5.2 ) Obstruction: Patients should maintain adequate hydration in days following barium sulfate procedure to avoid obstruction or impaction by baroliths ( 5.3 ) Aspiration Pneumonitis: Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration ( 5.4 )

5.1Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include: hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions.

Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.

5.2Intra-abdominal Barium Leakage Administration of VARIBAR PUDDING may result in leakage of barium from the GI tract in the presence of conditions and ailments that increase the risk of perforation such as known carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the gastrointestinal tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation.

The use of VARIBAR PUDDING is contraindicated in patients at high risk of perforation of the GI tract [see Contraindications ( 4 )] .

5.3Delayed Gastrointestinal Transit and Obstruction Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, with impaired gastrointestinal motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. [see Use in Specific Populations ( 8.4 , 8.5 )] .

To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure and consider the administration of laxatives.

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. In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR PUDDING.

The use of VARIBAR PUDDING is contraindicated in patients with trachea-esophageal fistula [see Contraindications ( 4 )] . Monitor the patient closely for aspiration, discontinue administration of VARIBAR PUDDING if aspiration is suspected, and monitor for development of aspiration pneumonitis.

5.5Systemic Embolization Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel 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. Although this complicat…

🤒 Adverse Reactions 111 words

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the 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 Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary VARIBAR PUDDING is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. [see Clinical Pharmacology ( 12.3 )]

8.2Lactation Risk Summary VARIBAR PUDDING is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the infant to the drug. [see Clinical Pharmacology ( 12.3 )]

8.4Pediatric Use The efficacy of VARIBAR PUDDING in pediatric patients above 6 months of age is based on successful opacification of the pharynx during modified barium swallow examinations [see Clinical Pharmacology ( 12.1 )] . Safety and dosing recommendations in pediatric patients above 6 months of age are based on clinical experience [see Indications ( 1 ), Dosage and Administration ( 2.1 )] . VARIBAR PUDDING is contraindicated in pediatric patients with tracheo-esophageal fistula. [see Contraindications ( 4 )] .

Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions ( 5.3 )] .

8.5Geriatric Use Clinical studies of VARIBAR PUDDING did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient 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

🤰 Pregnancy 33 words

8.1Pregnancy Risk Summary VARIBAR PUDDING is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. [see Clinical Pharmacology ( 12.3 )]

🧒 Pediatric Use 133 words

8.4Pediatric Use The efficacy of VARIBAR PUDDING in pediatric patients above 6 months of age is based on successful opacification of the pharynx during modified barium swallow examinations [see Clinical Pharmacology ( 12.1 )] . Safety and dosing recommendations in pediatric patients above 6 months of age are based on clinical experience [see Indications ( 1 ), Dosage and Administration ( 2.1 )] . VARIBAR PUDDING is contraindicated in pediatric patients with tracheo-esophageal fistula. [see Contraindications ( 4 )] .

Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions ( 5.3 )] .

🧓 Geriatric Use 84 words

8.5Geriatric Use Clinical studies of VARIBAR PUDDING did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient 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

🧬 Clinical Pharmacology 73 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Due to its high atomic number, barium (the active ingredient in VARIBAR PUDDING) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2Pharmacodynamics Barium sulfate is biologically inert and has no known pharmacological effects.

12.3Pharmacokinetics Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

🧬 Mechanism of Action 32 words

12.1Mechanism of Action Due to its high atomic number, barium (the active ingredient in VARIBAR PUDDING) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

📦 How Supplied / Storage and Handling 155 words

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied VARIBAR PUDDING is an off-white to lightly colored ready-to-use paste with a vanilla aroma for oral administration supplied in multiple-dose polyethylene tubes containing either 30 mL or 230 mL of barium sulfate (40% w/v). Provided as: 24 X 30 mL tubes (NDC 32909-125-54); 12 X 230 mL tubes (NDC 32909-125-22)

16.2Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from freezing. Once opened, VARIBAR PUDDING may be used for up to 21 days when stored at USP controlled room temperature, 20°C to 25°C (68°F to 77°F).

16.1How Supplied VARIBAR PUDDING is an off-white to lightly colored ready-to-use paste with a vanilla aroma for oral administration supplied in multiple-dose polyethylene tubes containing either 30 mL or 230 mL of barium sulfate (40% w/v). Provided as: 24 X 30 mL tubes (NDC 32909-125-54); 12 X 230 mL tubes (NDC 32909-125-22)

📦 Storage and Handling 44 words

16.2Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from freezing. Once opened, VARIBAR PUDDING may be used for up to 21 days when stored at USP controlled room temperature, 20°C to 25°C (68°F to 77°F).

📋 Description 93 words

11 DESCRIPTION VARIBAR PUDDING (barium sulfate) is a radiographic contrast agent that is supplied as a 40 % w/v ready to use paste with a vanilla aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol and the following chemical structure: VARIBAR PUDDING has a viscosity of 5000 cPs and contains the following excipients: artificial vanilla flavor, carboxymethylcellulose sodium, citric acid, ethyl vanillin, glycerin, maltodextrin, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, xanthan gum, and xylitol. barium-sulfate-structure

💬 Information for Patients 69 words

17 PATIENT COUNSELING INFORMATION After administration, advise patients to: Maintain adequate hydration. Seek medical attention for worsening of constipation or slow gastrointestinal passage. Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty.

Rx only Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08540 by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 VARIBAR ® is a registered trademark of E-Z-EM, Inc. Revised: May 2025 CL87D-05

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