Cystografin
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Cystografin
- Generic name
- DIATRIZOATE MEGLUMINE
- Manufacturer
- BRACCO DIAGNOSTICS INC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 7496d736-9f7d-4136-ad5d-b24c7803c21b
- SPL ID
- 6b067ea9-50b4-0ec7-1f1c-e07b00faced4
- Version
- 7
- Effective date
- 2025-11-23
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:27:28
| Harmonized routes |
|---|
| INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 010040 | derived:openfda.application_number |
| application number | NDA010040 | openfda.application_number | |
| brand name | Cystografin | openfda.brand_name | |
| generic name | DIATRIZOATE MEGLUMINE | openfda.generic_name | |
| manufacturer name | BRACCO DIAGNOSTICS INC | openfda.manufacturer_name | |
| ndc | package | 0270-0149-57 | openfda.package_ndc |
| ndc | package | 0270-0149-60 | openfda.package_ndc |
| ndc | product | 0270-0149 | openfda.product_ndc |
| ndc11 | package | 00270014960 | derived:openfda.package_ndc |
| ndc11 | package | 00270014957 | derived:openfda.package_ndc |
| spl id | 6b067ea9-50b4-0ec7-1f1c-e07b00faced4 | id | |
| spl set id | 7496d736-9f7d-4136-ad5d-b24c7803c21b | set_id | |
| unii | 3X9MR4N98U | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Severe sensitivity reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, or previous reactions to contrast agents. A history of sensitivity to iodine per se or to other contrast agents is not an absolute contraindication to the use of diatrizoate meglumine, but calls for extreme caution in administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Retrograde genitourinary procedures may cause such complications as hematuria, perforation of the urethra or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria. If intravasation of this drug occurs, the reactions which may be associated with intravenous administration may possibly be encountered. Hypersensitivity or anaphylactoid reactions may occur. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. Endocrine: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants. Some patients were treated for hypothyroidism.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.