Home NDC 0270-1411 ISOVUE-M
Product NDC 0270-1411
11-digit product format 002701411
Labeler code 0270
Product ID 0270-1411_07cc86aa-255e-f459-c9c5-747f57811163
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IOPAMIDOL
Dosage form INJECTION, SOLUTION
Route INTRATHECAL
Labeler Bracco Diagnostics Inc
Application NDA018735
Marketing category NDA
Marketing start 1985-12-31
Substance IOPAMIDOL
Active strength 408 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-M
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOPAMIDOL 408 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii JR13W81H44
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0270-1411-11 ISOVUE-M 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 10 0270-1411-11 ISOVUE-M 10 in 1 PACKAGE INJECTION, SOLUTION 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IOPAMIDOL ACTIVE INGREDIENT JR13W81H44 ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 3 IOPAMIDOL ACTIVE MOIETY JR13W81H44 ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 3 edetate calcium disodium INACTIVE INGREDIENT 25IH6R4SGF ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 3 tromethamine INACTIVE INGREDIENT 023C2WHX2V ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 3 Iopamidol ACTIVE INGREDIENT JR13W81H44 ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] 2 Iopamidol ACTIVE MOIETY JR13W81H44 ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] 2 Edetate Calcium Disodium INACTIVE INGREDIENT 25IH6R4SGF ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] 2 Tromethamine INACTIVE INGREDIENT 023C2WHX2V ISOVUE-M 200 (IOPAMIDOL) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-1411 ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] 8 Current NDC, Legacy NDC, 2 package rows 20221108_11e893d2-0183-4581-b908-c8b7302c7edb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0270-1411-11 00270141111 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-11) / 10 mL in 1 VIAL, SINGLE-DOSE 1985-12-31 0000-00-00 No No Current 0270-1411-25 00270141125 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1411-25) > 20 mL in 1 VIAL, SINGLE-DOSE 1985-12-31 2023-10-31 No No Current