FDA.reportPublic FDA data

ISOVUE

Product NDC
0270-1316
11-digit product format
002701316
Labeler code
0270
Product ID
0270-1316_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
755 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
370
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IOPAMIDOL755 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
0270-1316-04ISOVUE370125 mL in 1 BOTTLEINJECTION, SOLUTION12522
0270-1316-04ISOVUE37010 in 1 BOXINJECTION, SOLUTION1022
0270-1316-30ISOVUE37010 in 1 BOXINJECTION, SOLUTION1022
0270-1316-30ISOVUE37050 mL in 1 VIALINJECTION, SOLUTION5022
0270-1316-35ISOVUE37010 in 1 BOXINJECTION, SOLUTION1022
0270-1316-35ISOVUE370100 mL in 1 BOTTLEINJECTION, SOLUTION10022
0270-1316-37ISOVUE37010 in 1 BOXINJECTION, SOLUTION1022
0270-1316-37ISOVUE370150 mL in 1 BOTTLEINJECTION, SOLUTION15022
0270-1316-52ISOVUE37010 in 1 BOXINJECTION, SOLUTION1022
0270-1316-52ISOVUE37075 mL in 1 BOTTLEINJECTION, SOLUTION7522
0270-1316-45ISOVUE37010 in 1 BOXINJECTION, SOLUTION1015
0270-1316-45ISOVUE370200 mL in 1 BOTTLEINJECTION, SOLUTION20015
0270-1316-95ISOVUE3706 in 1 BOXINJECTION, SOLUTION615
0270-1316-95ISOVUE370500 mL in 1 BOTTLEINJECTION, SOLUTION50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0270-1316-01ML - Milliliter0270-13163bef85ba-5914-4bc7-a471-51436d884ce512012-07-24
0270-1316-04ML - Milliliter0270-1316f1506f20-fc45-4045-80c6-a496a308fe4512012-07-24
0270-1316-30ML - Milliliter0270-1316f5b2927c-e4fd-49a6-a68b-a8d74e397ebd12015-08-04
0270-1316-35ML - Milliliter0270-1316040b8526-a0e3-4321-b137-62a9811eb72712012-07-24
0270-1316-37ML - Milliliter0270-13161e8fc5bf-29cf-499f-b11f-ebae22179e7212012-07-24
0270-1316-41ML - Milliliter0270-13169444b013-4a98-4866-a69f-a534dc4b194212012-07-24
0270-1316-45ML - Milliliter0270-1316ace099aa-7e12-4751-95c9-4fab40ff284e12015-09-10
0270-1316-52ML - Milliliter0270-1316f7bb58ac-24db-4812-b2ff-308060e398be12012-07-24
0270-1316-95ML - Milliliter0270-1316c1c9bf8e-b14e-417c-b26d-28b8fd8f841112015-09-10
0270-1316-98ML - Milliliter0270-13169164d072-c3d8-4c56-939f-f0056054b45b12012-07-24

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
0270-1316ISOVUE 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, 10 package rows20250112_ae8c18c9-3e7d-4515-b980-120025a88fc1.zip
0270-1316ISOVUE 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
0270-1316-040027013160410 BOTTLE in 1 BOX (0270-1316-04) / 125 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1316-300027013163010 VIAL in 1 BOX (0270-1316-30) / 50 mL in 1 VIAL10 vial1985-12-310000-00-00NoNoCurrent
0270-1316-350027013163510 BOTTLE in 1 BOX (0270-1316-35) / 100 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1316-370027013163710 BOTTLE in 1 BOX (0270-1316-37) / 150 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1316-410027013164110 BOTTLE in 1 BOX (0270-1316-41) > 200 mL in 1 BOTTLE10 bottle1994-10-122021-11-01NoNoCurrent
0270-1316-450027013164510 BOTTLE in 1 BOX (0270-1316-45) / 200 mL in 1 BOTTLE10 bottle2014-06-200000-00-00NoNoCurrent
0270-1316-520027013165210 BOTTLE in 1 BOX (0270-1316-52) > 75 mL in 1 BOTTLE10 bottle1985-12-310000-00-00NoNoCurrent
0270-1316-95002701316956 BOTTLE in 1 BOX (0270-1316-95) / 500 mL in 1 BOTTLE6 bottle2014-06-200000-00-00NoNoCurrent
0270-1316-98002701316986 BOTTLE in 1 BOX (0270-1316-98) > 500 mL in 1 BOTTLE6 bottle1994-10-122021-11-01NoNoCurrent