Prescription medicine
Diatrizoate Brand names: Cystografin, Gastrografin; first approved as Hypaque Sodium
Diatrizoate (Gastrografin) is a prescription medicine with an FDA approval on record since 1954. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the diatrizoate FDA label on DailyMed (effective January 1, 2021, Liebel-Flarsheim Company LLC); the NDA 9561 record on Drugs@FDA; every diatrizoate label on DailyMed.
Highlights of the record
FDA label of January 1, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon).
Forms and strengths
- 180 mg/ml
- 300 mg/ml
- 600 mg/ml / 100 mg/ml
- 660 mg/ml / 100 mg/ml
Solution; injection (solution); liquid.
On the market
- Earliest approval on file
- November 26, 1954 Hypaque Sodium 20%, Ge Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first July 2, 1980; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest April 13, 2022
- FAERS reports
- 520 through July 30, 2026
What is diatrizoate used for?
From the label: indications and usageMD-Gastroview (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 pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (MD GASTROVIEW), Liebel-Flarsheim Company LLC, effective January 1, 2021 (SPL set b348b1cf-6250-4ab6-b2bf-3bff86628c53), via openFDA; the full label on DailyMed
Is there a generic for diatrizoate (Gastrografin)?
The FDA approved the first generic diatrizoate on July 2, 1980. 13 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists diatrizoate from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1954 earliest approval on file
- 1980 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has diatrizoate been recalled?
The FDA's Enforcement Report lists 3 recalls naming diatrizoate since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| May 15, 2015 | Class II | Mallinckrodt, Inc. | Labeling: incorrect or missing lot number and/or expiration date |
| June 21, 2013 | Class II | Bracco Diagnostics Inc | Presence of foreign substance: One lot of the product may contain black foreign particles |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for diatrizoate?
The FDA Adverse Event Reporting System holds 520 reports that list diatrizoate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 141 are coded as a death and 262 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radiographic contrast agents
- the pharmacologic class, with prices and generics
- Diatrizoate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other