Cystografin

Product NDC
0270-0149
11-digit product format
002700149
Labeler code
0270
Product ID
0270-0149_6b067ea9-50b4-0ec7-1f1c-e07b00faced4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diatrizoate meglumine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA010040
Marketing category
NDA
Marketing start
1970-11-03
Substance
DIATRIZOATE MEGLUMINE
Active strength
300 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cystografin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIATRIZOATE MEGLUMINE300 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X9MR4N98U

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a8f1679b-19b1-407c-9ee3-d33055bee6fcProduct name220250731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0270-0149-57Cystografin10 in 1 PACKAGEINJECTION, SOLUTION107
0270-0149-57Cystografin300 mL in 1 BOTTLEINJECTION, SOLUTION3007
0270-0149-60Cystografin10 in 1 PACKAGEINJECTION, SOLUTION107
0270-0149-60Cystografin100 mL in 1 BOTTLEINJECTION, SOLUTION1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-0149-57ML - Milliliter0270-0149edfa8868-1b15-483d-890e-b15b2c83dd5412013-02-13
0270-0149-60ML - Milliliter0270-01497e901fa0-0046-48d2-af20-0a7abca18e1412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diatrizoate meglumineACTIVE INGREDIENT3X9MR4N98UCYSTOGRAFIN (DIATRIZOATE MEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]5
diatrizoic acidACTIVE MOIETY5UVC90J1LKCYSTOGRAFIN (DIATRIZOATE MEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]5
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCYSTOGRAFIN (DIATRIZOATE MEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-0149CYSTOGRAFIN (DIATRIZOATE MEGLUMINE) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]6Current NDC, Legacy NDC, 4 package rows20181010_7496d736-9f7d-4136-ad5d-b24c7803c21b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0270-0149-570027001495710 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE10 bottle1970-11-030000-00-00NoNoCurrent
0270-0149-600027001496010 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE10 bottle1970-11-030000-00-00NoNoCurrent