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Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL Solution, 120 mL — NDC 53041-0690-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL Solution, 120 mL — NDC 53041-690-03 (Billing 53041-0690-03)

by Guardian Drug Company · 120 mL in 1 BOTTLE, GLASS

This is a package of 120 mL of Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL Solution from Guardian Drug Company, marketed since Dec 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 53041-0690-03
🏷️ FDA NDC (as labeled) 53041-690-03 billing pads the product segment with a zero
This package
Contains120 mL Pack sizes2 compare ↓
Main listing for product 53041-690 · Also comes in: 30 ml 53041-690-09
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53041-690-03
Product NDC 53041-690
11-digit billing NDC 53041069003
UNII V5403H8VG7, 3X9MR4N98U
Application # ANDA214201
SPL Set ID e9da4d3d-d0ca-44f7-aaeb-ae49c3839775
Established class (EPC) Radiographic Contrast Agent
Mechanism of action X-Ray Contrast Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-18
Route ORAL, RECTAL
Dosage form SOLUTION
Substance DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 008270
GCN 89190
HICL code 003693
Ingredient (HICL) Diatrizoate Meglumine, Sodium
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 DIATRIZOATE MEGLUM-SOD 66%-10%
FDB brand name Diatrizoate Meglumine-Sodium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 008270
  • GCN: 89190
  • HICL (First Databank): 003693
  • AHFS class code: 36:68.00.00
Why two NDCs? The FDA registers this code as 53041-690-03 — 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 → 53041-0690-03. 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.

Clinical

Label name DIATRIZOATE MEGLUM-SOD 66%-10% Ingredient Diatrizoate Meglumine, Sodium

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: 30 ml
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
53041-0690-03 You're viewing this Main listing 120 mL in 1 BOTTLE, GLASS 2019-12-18 — Active
53041-0690-09 53041-690-09 30 mL in 1 BOTTLE, GLASS 2019-12-18 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 120 mL — 120 ml in 1 bottle, glass.
How does this package differ from NDC 53041-0690-09?
Both are Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL Solution — the drug itself is identical. This page's package is the 120 mL one, while NDC 53041-0690-09 is the 30 ml package.
What NDC number is used to bill for this package of Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL 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
Gastrografin 660 mg/mL; 100 mg/mL 00270-0445-35 Bracco 24 bottles — AA FDA listed —
Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL 53041-0688-03 Guardian 120 ml — AA FDA listed —
Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mLthis 53041-0690-03 Guardian 120 ml — AA FDA listed —
Diatrizoate Meglumine and Diatrizoate Sodium 660 mg/mL; 100 mg/mL 31722-0019-12 Camber 12 bottles — AA FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

FlavorLemon
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerGuardian Drug Company
Application holderANDA REPOSITORY LLC
FDA applicationANDA214201 (ANDA)
Labeler code53041
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio46 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.

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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 112 words ▾

INDICATIONS & USAGE Diatrizoate Meglumine and Diatrizoate Sodium Solution is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. Diatrizoate Meglumine and Diatrizoate Sodium Solution may also be used as an adjunct to contrast enhancement is computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology.

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE & ADMINISTRATION General This medium is not to be used for the preparations of solutions for parenteral administration. Oral or rectal administration only. Discard any unused portion after procedure.

The routine preparatory measures employed for barium studies are also appropriate for this agent. For pediatric and severely cachectic patients the maintenance of an intravenous fluid line may be advisable. Radiographic Examination of Segments of the Gastrointestinal Tract Oral Administration: Adult oral dosage may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature of the examination and the size of the patient.

For infants and children less than 5 years of age, 30 mL (11 g iodine) are usually adequate; for children 5 to 10 years of age, the suggested dose is 60 mL (22 g iodine). These pediatric doses may be diluted 1:1, if desired, with water, carbonated beverage, milk or mineral oil. When used in infants, the solution may be given in a nursing bottle.

Pediatric doses may also be used in dehydrated and/or debilitated adult patients. A 1:1 dilution is also recommended when the contrast medium is used in elderly cachectic individuals. For very young (under 10 kg) and debilitated children the dose should be diluted: 1 part Diatrizoate Meglumine and Diatrizoate Sodium Solution in 3 parts water is recommended.

For Enemas or Enterostomy Instillations: Diatrizoate Meglumine and Diatrizoate Sodium Solution should be diluted when it is used for enemas and enterostomy instillations. When used as an enema, the suggested dilution for adults is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under 5 years of age, a 1:5 dilution in tap water is suggested; for children over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is a suitable dilution.

Tomography (Body Imaging) A usual adult dose is 240 mL of a dilute Diatrizoate Meglumine and Diatrizoate Sodium Solution prepared by diluting 25 mL (9.17 g iodine) to one liter with tap water. Less dilute solutions [up to 77 mL (28.26 g iodine) diluted to one liter with tap water] may be used when indicated. The dose is administered orally about 15 to 30 minutes prior to imaging in order to permit the contrast medium to reach the pelvic loops.

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Do not administer to patients with a known hypersensitivity to Diatrizoate Meglumine and Diatrizoate Sodium Solution or any of its components.

⚠️ Warnings ~2 min read ▾

WARNINGS Dehydration: Administration of hypertonic Diatrizoate Meglumine and Diatrizoate Sodium Solution may lead to hypovolemia and hypotension due to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Diatrizoate Meglumine and Diatrizoate Sodium Solution yields an approximately isotonic 16.5 percent diatrizoate salts solution; less dilute solutions are hypertonic and may lead to intraluminal movement of fluid with resulting hypovolemia. In young or debilitated children and in elderly cachectic persons, the loss of plasma fluid may be sufficient to cause a shock-like state.

If Diatrizoate Meglumine and Diatrizoate Sodium Solution is used in infants and children (under 10 kg) or in dehydrated or debilitated patients, the solution must be prepared using the specific dilutions described in DOSAGE AND ADMINISTRATION . In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential. In pediatric or severely debilitated patients, the maintenance of an open intravenous fluid line for rehydration may be advisable should hypotension or shock supervene.

Electrolyte disturbances must be corrected prior to the administration of any hypertonic Diatrizoate Meglumine and Diatrizoate Sodium Solution. Aspiration: Aspiration of Diatrizoate Meglumine and Diatrizoate Sodium Solution into the trachea and airways may result in serious pulmonary complications including, pulmonary edema, pneumonitis or death Bronchial entry of any orally administered contrast medium causes a copious osmotic effusion. Therefore, avoid use of Diatrizoate Meglumine and Diatrizoate Sodium Solution in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients.

If Diatrizoate Meglumine and Diatrizoate Sodium Solution is given by nasogastric tube, the position of the tube in the stomach must be verified before administration. Anaphylactic reactions: Anaphylactic reactions, including fatalities, have been reported with the use of Diatrizoate Meglumine and Diatrizoate Sodium Solution. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).

Medical personnel trained in the treatment of anaphylactic reactions and the necessary drugs and medical equipment should always be readily available when Diatrizoate Meglumine and Diatrizoate Sodium Solution is used.

🤒 Adverse Reactions 90 words ▾

ADVERSE REACTIONS Most adverse reactions to enteral diagnostic radiopaque agents are mild and transitory. Nausea, vomiting and/or diarrhea, urticaria with erythema, hypoxia, acute dyspnea, tachyarrhythmia, and anaphylaxis have occurred following ingestion of the contrast medium, particularly when high concentrations of large volumes of solution are administered. Severe changes in serum osmolarity and electrolyte concentrations may produce shock-like states (see WARNINGS ).

It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.

🔄 Drug / Laboratory Test Interactions 152 words ▾

DRUG & OR LABORATORY TEST INTERACTIONS Thyroid Function Tests The results of protein bound iodine (PBI) and radioactive iodine uptake studies, which depend on iodine estimations, will not accurately reflect thyroid function for six months, and possibly as long as one year, following the administration of diagnostic enteral radiopaque media. Thyroid function tests, if indicated, generally should be performed prior to the administration of any iodinated agent. However, thyroid function can be evaluated after use of these agents by using T 3 resin uptake and total or free thyroxine (T 4 ) assays which are not dependent on iodine estimations.

Pancreatic Tests Small quantities of contrast medium in the intestinal tract may cause false low trypsin values when determined spectrophotometrically. Therefore, duodenal instillation should not precede pancreatic function tests involving spectrophotometric trypsin assays. Any test which might be affected by contrast media should be performed prior to administration of the contrast medium.

🤰 Pregnancy 91 words ▾

PREGNANCY When administered intravenously, diatrizoate salts cross the placenta and are evenly distributed in fetal tissues. No teratogenic effects attributable to diatrizoate meglumine or diatrizoate sodium have been observed in teratology studies performed in animals. There are, however, no adequate and well-controlled studies in pregnant women.

Because small amounts of these agents may be absorbed, and animal teratology studies are not always predictive of human response, these agents should be used during pregnancy only when clearly needed. Procedures including radiation involve a certain risk related to the exposure of the fetus.

🧒 Pediatric Use 63 words ▾

PEDIATRIC USE See WARNINGS , and PRECAUTIONS , General Local injury to the colonic mucosa, particularly in the presence of underlying disease which interferes with intestinal viability, has been reported in cases where recommended doses and dilutions (see DOSAGE AND ADMINISTRATION ) were not used; when extemporaneous dosage is elected, the polysorbate 80 level in the dose may be contributing factor to injury.

🆘 Overdosage 51 words ▾

OVERDOSAGE See WARNINGS regarding potential hypovolemia, hypotension, or shock. The maintenance of an open intravenous fluid line for rehydration may be advisable. See DOSAGE AND ADMINISTRATION for appropriate doses and dilutions. Treatment of an overdose should be directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

🧬 Clinical Pharmacology 164 words ▾

CLINICAL PHARMACOLOGY The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast with surrounding tissues. Diagnostic enteral radiopaque agents have few known pharmacological effects.

Diatrizoate meglumine and diatrizoate sodium exert a mild laxative effect attributable to their high osmolarity. Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed from the intact gastrointestinal tract, and therefore permit gastrointestinal opacification and delineation after oral or rectal administration. Oral administration is used for radiographic evaluation of the esophagus, stomach and proximal small intestine.

Rectal administration is used for examination of the colon; however, visualization of the distal small bowel is generally unsatisfactory, since the hypertonicity of the medium causes intraluminal diffusion of water with subsequent dilution of the medium. Enough absorption from the gastrointestinal tract to permit incidental visualization of urinary tract has been reported; this should be considered when thyroid testing is being contemplated, since iodine-mediated thyrotropic effects may occur (see PRECAUTIONS) .

📦 How Supplied / Storage and Handling 84 words ▾

HOW SUPPLIED Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a clear, colorless to pale yellow liquid with citrus aroma and is available in packages of: NDC 53041-690-09 Twenty-four 30 mL single dose bottles NDC 53041-690-03 Twelve 120 mL single dose bottles NDC 53041-688-03 Twelve 120 mL single dose bottles (PET) Storage Protect from light. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]; avoid excessive heat. Discard unused portion.

Manufactured by: Guardian Drug Company 2 Charles Court, Dayton, New Jersey 08810 Revised: 08/2020

📋 Description 147 words ▾

DESCRIPTION Diatrizoate Meglumine and Diatrizoate Sodium Solution USP is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine.

Inactive ingredients: edetate disodium, flavor, hydrochloric acid, polysorbate 80, purified water, saccharin sodium, simethicone, sodium citrate and sodium hydroxide. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas: Diatrizoate Meglumine C 11 H 9 I 3 N 2 O 4 .C 7 H 17 NO 5 MW 809.13 Organically Bound Iodine: 47.1% CAS – 131-49-7 Diatrizoate Sodium C 11 H 8 I 3 N 2 NaO 4 MW 635.90 Organically Bound Iodine: 59.9% CAS – 737-31-5 111 112

💬 Information for Patients 95 words ▾

INFORMATION FOR PATIENTS Patients should receive the following information and instructions: This drug has been prescribed to perform an x-ray of the gastrointestinal tract. Inform the physician if pregnant or if allergic to iodine, any foods, or x-ray materials. The iodine in diatrizoate salts may interfere with some thyroid tests if these are needed in the future.

Inform the attending physician at that time about this gastrointestinal study. This drug may cause abdominal cramping, nausea, vomiting, diarrhea, skin rashes, itching, heartburn, dizziness, or headache in some patients, but most reactions are mild and pass quickly

⚠️ Precautions ~3 min read ▾

PRECAUTIONS GENERAL PRECAUTIONS Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of administration, as well as for treatment of reaction to the contrast medium (see ADVERSE REACTIONS , and PRECAUTIONS , Information for the Patient ). Rectal administration of undiluted Diatrizoate Meglumine and Diatrizoate Sodium Solution in any patient, particularly with large doses and/or in those with overdistention, has been reported to be associated with mucosal irritation.

Cases of hyperthyroidism have been reported with the use of oral contrast media. Some of these patients reportedly had multinodular goiters which may have been responsible for the increased hormone synthesis in response to excess iodine. Administration of an intravascular iodinated radiopaque diagnostic agent to a hyperthyroid patient precipitated thyroid storm; a similar situation could follow administration of oral preparations of iodides.

Therefore, caution should be exercised when administering enteral gastrointestinal radiopaque agents to hyperthyroid and euthyroid goiterous patients. Consideration should be given to the potential for precipitation of water-soluble contrast agents under conditions that may promote hyperacidity (i.e., fasting, emotional upset, or stress). Harmful effects directly attributable to precipitate formation have not been reported.

However, the possibility of interpreting the precipitate radiologically as an anatomical abnormality (i.e., ulceration of the stomach or small intestine) or injury, should be kept in mind. INFORMATION FOR PATIENTS Patients should receive the following information and instructions: This drug has been prescribed to perform an x-ray of the gastrointestinal tract. Inform the physician if pregnant or if allergic to iodine, any foods, or x-ray materials.

The iodine in diatrizoate salts may interfere with some thyroid tests if these are needed in the future. Inform the attending physician at that time about this gastrointestinal study. This drug may cause abdominal cramping, nausea, vomiting, diarrhea, skin rashes, itching, heartburn, dizziness, or headache in some patients, but most reactions are mild and pass quickly DRUG & OR LABORATORY TEST INTERACTIONS Thyroid Function Tests The results of protein bound iodine (PBI) and radioactive iodine uptake studies, which depend on iodine estimations, will not accurately reflect thyroid function for six months, and possibly as long as one year, following the administration of diagnostic enteral radiopaque media.

Thyroid function tests, if indicated, generally should be performed prior to the administration of any iodinated agent. However, thyroid function can be evaluated after use of these agents by using T 3 resin uptake and total or free thyroxine (T 4 ) assays which are not dependent on iodine estimations. Pancreatic Tests Small quantities of contrast medium in the intestinal tract may cause false low trypsin values when determined spectrophotometrically.

Therefore, duodenal instillation should not precede pancreatic function tests involving spectrophotometric trypsin assays. Any test which might be affected by contrast media should be performed prior to administration of the contrast medium. CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females PREGNANCY When administered intravenously, diatrizoate salts cross the placenta and are evenly distributed in fetal tissues.

No teratogenic effects attributable to diatrizoate meglumine or diatrizoate sodium have been observed in teratology studies performed in animals. There are, however, no adequate and well-controll… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 40 words ▾

NURSING MOTHERS Diatrizoate meglumine is excreted in breast milk following intravascular administration. Because small amounts of enteral gastrointestinal radiopaque agents may be absorbed following oral or rectal administration, caution should be exercised when they are administered to a nursing woman.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 30 words ▾

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females

📄 Package Label / Principal Display Panel 139 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 53041-690-09 37% Organically Bound Iodine Diatrizoate Meglumine and Diatrizoate Sodium Solution USP For oral or rectal use only Do Not Inject Rx only 30 mL Guardian NDC 53041-690-09 24 x 30 mL Bottle Shipper/case label Diatrizoate Meglumine and Diatrizoate Sodium Solution USP NDC 53041-690-03 37% Organically Bound Iodine Diatrizoate Meglumine and Diatrizoate Sodium Solution USP For oral or rectal use only Do Not Inject Rx only 120 mL Guardian NDC 53041-690-03 12 x 120 mL Bottle Shipper/case label Diatrizoate Meglumine and Diatrizoate Sodium Solution USP NDC 53041-688-03 37% Organically Bound Iodine Diatrizoate Meglumine and Diatrizoate Sodium Solution USP For oral or rectal use only Do Not Inject Rx only 120 mL Guardian NDC 53041-688-03 12 x 120 mL Bottle Shipper/case label Diatrizoate Meglumine and Diatrizoate Sodium Solution USP 69030 69030case 690120 690120case 688120 688120case

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

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 Diatrizoate Meglumine and Diatrizoate Sodium — the ingredient across all brands.

Top reported reactions

Urticaria31
Diarrhoea26
Nausea24
Vomiting23
Pruritus19
Dyspnoea16
Rash13

Age at onset

Neonate2
Infant1
Adolescent1
Adult24
Elderly16

Reporter sex

373 reports
Male · 49%
Female · 49%
Unknown · 2%

Serious outcomes

Hospitalization149
Death55
Life-threatening45
Disabling5
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25 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.

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 ✓ Available
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 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 Guardian Drug Company. 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 30 ml (53041-0690-09). 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?
Guardian Drug Company 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.
← 53041-0688-03 · Guardian 53041-0717-23 · Guardian →
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.