isovue 300

Generic: iopamidol

Labeler: bracco diagnostics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name isovue 300
Generic Name iopamidol
Labeler bracco diagnostics inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVASCULAR
Active Ingredients

iopamidol 612 mg/mL

Manufacturer
BRACCO DIAGNOSTICS INC

Identifiers & Regulatory

Product NDC 0270-1315
Product ID 0270-1315_653334ec-0509-a520-afb3-b8e073157cb6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018735
Listing Expiration 2026-12-31
Marketing Start 1985-12-31

Pharmacologic Class

Established (EPC)
radiographic contrast agent [epc]
Mechanism of Action
x-ray contrast activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02701315
Hyphenated Format 0270-1315

Supplemental Identifiers

UNII
JR13W81H44
NUI
N0000180185 N0000010258

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name isovue 300 (source: ndc)
Generic Name iopamidol (source: ndc)
Application Number NDA018735 (source: ndc)
Routes
INTRAVASCULAR
source: ndc

Resolved Composition

Strengths
  • 612 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) / 50 mL in 1 VIAL, SINGLE-DOSE
  • 10 BOTTLE in 1 BOX (0270-1315-35) / 100 mL in 1 BOTTLE
  • 10 BOTTLE in 1 BOX (0270-1315-50) / 150 mL in 1 BOTTLE
source: ndc

Packages (4)

0270-1315-25 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25) / 30 mL in 1 VIAL, SINGLE-DOSE 0270-1315-30 10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30) / 50 mL in 1 VIAL, SINGLE-DOSE 0270-1315-35 10 BOTTLE in 1 BOX (0270-1315-35) / 100 mL in 1 BOTTLE 0270-1315-50 10 BOTTLE in 1 BOX (0270-1315-50) / 150 mL in 1 BOTTLE

Ingredients (1)

iopamidol (612 mg/mL)

Linked Drug Pages (2)

ISOVUE 200, ISOVUE 300, ISOVUE 370, ISOVUE 250 ndc-match (0.9) ISOVUE 300, ISOVUE 370 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVASCULAR"], "spl_id": "653334ec-0509-a520-afb3-b8e073157cb6", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["JR13W81H44"], "spl_set_id": ["ae8c18c9-3e7d-4515-b980-120025a88fc1"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["BRACCO DIAGNOSTICS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-25)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-1315-25", "marketing_start_date": "19851231"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 BOX (0270-1315-30)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0270-1315-30", "marketing_start_date": "19851231"}, {"sample": false, "description": "10 BOTTLE in 1 BOX (0270-1315-35)  / 100 mL in 1 BOTTLE", "package_ndc": "0270-1315-35", "marketing_start_date": "19851231"}, {"sample": false, "description": "10 BOTTLE in 1 BOX (0270-1315-50)  / 150 mL in 1 BOTTLE", "package_ndc": "0270-1315-50", "marketing_start_date": "19851231"}], "brand_name": "ISOVUE 300", "product_id": "0270-1315_653334ec-0509-a520-afb3-b8e073157cb6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0270-1315", "generic_name": "IOPAMIDOL", "labeler_name": "BRACCO DIAGNOSTICS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOVUE", "brand_name_suffix": "300", "active_ingredients": [{"name": "IOPAMIDOL", "strength": "612 mg/mL"}], "application_number": "NDA018735", "marketing_category": "NDA", "marketing_start_date": "19851231", "listing_expiration_date": "20261231"}