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Prescription medicine · generic available

Diatrizoate meglumine and diatrizoate sodium

Brand names: Md Gastroview, Gastrografin

Active ingredients: diatrizoate meglumine · diatrizoate sodium

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
3Recalls (FDA reports)
4Companies
1958First FDA approval on file

Quick answers

What is Diatrizoate meglumine and diatrizoate sodium used for?
The FDA-approved label (Gastrografin, Bracco Diagnostics Inc, October 4, 2021) says: “Gastrografin (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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Diatrizoate meglumine and diatrizoate sodium have a boxed warning?
No. None of the 4 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Diatrizoate meglumine and diatrizoate sodium?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Diatrizoate meglumine and diatrizoate sodium been recalled?
FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Diatrizoate meglumine and diatrizoate sodium?
4 companies list prescription products of Diatrizoate meglumine and diatrizoate sodium in the FDA NDC Directory, including Guardian Drug Company, Liebel-Flarsheim Company LLC and Camber Pharmaceuticals, Inc..

What Diatrizoate meglumine and diatrizoate sodium is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Gastrografin (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. …

— FDA label: Gastrografin, Bracco Diagnostics Inc, effective October 4, 2021. Read the full label on DailyMed →

The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 4 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsSolution · Liquid
RouteOral · Rectal
Prescription products5 in the FDA NDC Directory
Brand namesMd Gastroview, Gastrografin

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA011245
GASTROGRAFIN		 BraccoJanuary 17, 1958 16, latest August 29, 2005
2005: Manufacturing (CMC) · 2000: Manufacturing (CMC) · 1994: Labeling

Generic approvals (3)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. April 13, 2022 · Class II · Terminated · D-1086-2022

    cGMP deviations: Temperature abuse

    Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35 — Mckesson Medical-Surgical Inc. Corporate Office

  2. May 15, 2015 · Class II · Terminated · D-1132-2015

    Labeling: incorrect or missing lot number and/or expiration date

    MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc — Mallinckrodt, Inc.

  3. June 21, 2013 · Class II · Terminated · D-885-2013

    Presence of foreign substance: One lot of the product may contain black foreign particles

    Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-E — Bracco Diagnostics Inc

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

SPL set ID of the quoted label8c2340e4-2b42-45dc-8fac-9960e8172547
FDA labels (SPL)4
FDA applicationsNDA011245, 3 ANDA
Active ingredients (FDA)DIATRIZOATE MEGLUMINE / DIATRIZOATE SODIUM

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Gastrografin, Bracco Diagnostics Inc, effective October 4, 2021; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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