FDA.reportPublic FDA data

ISOVUE

Product NDC
0270-1315
11-digit product format
002701315
Labeler code
0270
Product ID
0270-1315_2cb2e0be-08b1-e446-01c5-b1c50f1e797c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IOPAMIDOL
Dosage form
INJECTION, SOLUTION
Route
INTRAVASCULAR
Labeler
BRACCO DIAGNOSTICS INC
Application
NDA018735
Marketing category
NDA
Marketing start
1985-12-31
Substance
IOPAMIDOL
Active strength
612 mg/mL
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ISOVUE
Brand name suffix
300
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOPAMIDOL612 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJR13W81H44

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
10141263-39cb-493e-b682-37b22a8d146dProduct name220250625
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0270-1315-25ISOVUE30030 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3022
0270-1315-25ISOVUE30010 in 1 BOXINJECTION, SOLUTION1022
0270-1315-30ISOVUE30050 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION5022
0270-1315-30ISOVUE30010 in 1 BOXINJECTION, SOLUTION1022
0270-1315-35ISOVUE30010 in 1 BOXINJECTION, SOLUTION1022
0270-1315-35ISOVUE300100 mL in 1 BOTTLEINJECTION, SOLUTION10022
0270-1315-50ISOVUE300150 mL in 1 BOTTLEINJECTION, SOLUTION15022
0270-1315-50ISOVUE30010 in 1 BOXINJECTION, SOLUTION1022
0270-1315-45ISOVUE300200 mL in 1 BOTTLEINJECTION, SOLUTION20015
0270-1315-45ISOVUE30010 in 1 BOXINJECTION, SOLUTION1015
0270-1315-95ISOVUE300500 mL in 1 BOTTLEINJECTION, SOLUTION50015
0270-1315-95ISOVUE3006 in 1 BOXINJECTION, SOLUTION615

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-1315-25ML - Milliliter0270-13150dc9198a-2a9a-4a1a-a945-bc58f5bde79512012-07-24
0270-1315-30ML - Milliliter0270-131513642719-bf18-4f68-99c2-a6c6d4b402a712012-07-24
0270-1315-35ML - Milliliter0270-131554db406c-c35e-4fe4-9f5f-6151eca0238312012-07-24
0270-1315-41ML - Milliliter0270-1315b402a207-02e4-41cc-9ed0-ea2adf34339c12012-07-24
0270-1315-45ML - Milliliter0270-131594e5eea3-7d32-4133-b370-35b28f61f5a912015-09-10
0270-1315-47ML - Milliliter0270-13151ba7874c-fb92-4fae-a4bd-d1d2a119a4fb12012-07-24
0270-1315-50ML - Milliliter0270-1315a287464b-235a-45ac-a4f4-c246fe617a5012012-07-24
0270-1315-95ML - Milliliter0270-1315594d19d8-5a96-44c7-9a17-dee34515394f12015-09-10
0270-1315-98ML - Milliliter0270-1315d0fdff84-5e2c-4697-b285-eb78a788039d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IOPAMIDOLACTIVE INGREDIENTJR13W81H44ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
IOPAMIDOLACTIVE MOIETYJR13W81H44ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]7
IOPAMIDOLACTIVE INGREDIENTJR13W81H44ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]2
IOPAMIDOLACTIVE MOIETYJR13W81H44ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]2
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]2
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0270-1315ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]19Current NDC, Legacy NDC, 8 package rows20250112_ae8c18c9-3e7d-4515-b980-120025a88fc1.zip
0270-1315ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC]13Current NDC, Legacy NDC, 4 package rows20230510_797a11d7-dcd4-43ff-311b-3b48a10da2f2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0270-1315-250027013152510 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSE1985-12-310000-00-00NoNoCurrent
0270-1315-300027013153010 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) / 50 mL in 1 VIAL, SINGLE-DOSE1985-12-310000-00-00NoNoCurrent
0270-1315-350027013153510 BOTTLE in 1 BOX (0270-1315-35) / 100 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1315-410027013154110 BOTTLE in 1 BOX (0270-1315-41) > 200 mL in 1 BOTTLE10 bottle1994-10-122021-11-01NoNoCurrent
0270-1315-450027013154510 BOTTLE in 1 BOX (0270-1315-45) / 200 mL in 1 BOTTLE10 bottle2014-06-200000-00-00NoNoCurrent
0270-1315-470027013154710 BOTTLE in 1 BOX (0270-1315-47) > 75 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1315-500027013155010 BOTTLE in 1 BOX (0270-1315-50) / 150 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1315-95002701315956 BOTTLE in 1 BOX (0270-1315-95) / 500 mL in 1 BOTTLE6 bottle2014-06-200000-00-00NoNoCurrent
0270-1315-98002701315986 BOTTLE in 1 BOX (0270-1315-98) > 500 mL in 1 BOTTLE6 bottle1994-10-122021-11-01NoNoCurrent