Home NDC 0270-1412 ISOVUE-M
Product NDC 0270-1412
11-digit product format 002701412
Labeler code 0270
Product ID 0270-1412_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 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-M
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IOPAMIDOL 612 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 0270-1412-15 ISOVUE-M 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 10 0270-1412-15 ISOVUE-M 10 in 1 PACKAGE INJECTION, SOLUTION 10 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0270-1412 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 0270-1412-15 00270141215 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0270-1412-15) / 15 mL in 1 VIAL, SINGLE-DOSE 1985-12-31 0000-00-00 No No Current