isovue 200

Generic: iopamidol

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

Drug Facts

Product Profile

Brand Name isovue 200
Generic Name iopamidol
Labeler bracco diagnostics inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVASCULAR
Active Ingredients

iopamidol 408 mg/mL

Manufacturer
BRACCO DIAGNOSTICS INC

Identifiers & Regulatory

Product NDC 0270-1314
Product ID 0270-1314_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 02701314
Hyphenated Format 0270-1314

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 200 (source: ndc)
Generic Name iopamidol (source: ndc)
Application Number NDA018735 (source: ndc)
Routes
INTRAVASCULAR
source: ndc

Resolved Composition

Strengths
  • 408 mg/mL
source: ndc
Packaging
  • 10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLE
source: ndc

Packages (1)

0270-1314-15 10 BOTTLE in 1 BOX (0270-1314-15) / 200 mL in 1 BOTTLE

Ingredients (1)

iopamidol (408 mg/mL)

Linked Drug Pages (1)

ISOVUE 200, ISOVUE 300, ISOVUE 370, ISOVUE 250 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 BOTTLE in 1 BOX (0270-1314-15)  / 200 mL in 1 BOTTLE", "package_ndc": "0270-1314-15", "marketing_start_date": "19851231"}], "brand_name": "ISOVUE 200", "product_id": "0270-1314_653334ec-0509-a520-afb3-b8e073157cb6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0270-1314", "generic_name": "IOPAMIDOL", "labeler_name": "BRACCO DIAGNOSTICS INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ISOVUE", "brand_name_suffix": "200", "active_ingredients": [{"name": "IOPAMIDOL", "strength": "408 mg/mL"}], "application_number": "NDA018735", "marketing_category": "NDA", "marketing_start_date": "19851231", "listing_expiration_date": "20261231"}