visipaque

Generic: iodixanol

Labeler: ge healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name visipaque
Generic Name iodixanol
Labeler ge healthcare inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVASCULAR
Active Ingredients

iodixanol 320 mg/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 0407-2223
Product ID 0407-2223_3bf8b69f-3b64-4112-b08a-53bbf6dd57e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020351
Listing Expiration 2026-12-31
Marketing Start 2003-09-09

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 04072223
Hyphenated Format 0407-2223

Supplemental Identifiers

UNII
HW8W27HTXX
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 visipaque (source: ndc)
Generic Name iodixanol (source: ndc)
Application Number NDA020351 (source: ndc)
Routes
INTRAVASCULAR
source: ndc

Resolved Composition

Strengths
  • 320 mg/mL
source: ndc
Packaging
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-17) / 100 mL in 1 BOTTLE, PLASTIC
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-21) / 200 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

0407-2223-16 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16) / 50 mL in 1 BOTTLE, PLASTIC 0407-2223-17 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-17) / 100 mL in 1 BOTTLE, PLASTIC 0407-2223-19 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19) / 150 mL in 1 BOTTLE, PLASTIC 0407-2223-21 10 BOTTLE, PLASTIC in 1 BOX (0407-2223-21) / 200 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

iodixanol (320 mg/mL)

Linked Drug Pages (2)

Visipaque ndc-match (0.9) Visipaque ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVASCULAR"], "spl_id": "3bf8b69f-3b64-4112-b08a-53bbf6dd57e8", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["HW8W27HTXX"], "spl_set_id": ["e9d87b8c-7695-4c0f-8e81-000dedb5f66d"], "pharm_class_epc": ["Radiographic Contrast Agent [EPC]"], "pharm_class_moa": ["X-Ray Contrast Activity [MoA]"], "manufacturer_name": ["GE Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-16)  / 50 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-2223-16", "marketing_start_date": "20030909"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-17)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-2223-17", "marketing_start_date": "20030909"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-19)  / 150 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-2223-19", "marketing_start_date": "20030909"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-2223-21)  / 200 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-2223-21", "marketing_start_date": "20030909"}], "brand_name": "Visipaque", "product_id": "0407-2223_3bf8b69f-3b64-4112-b08a-53bbf6dd57e8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0407-2223", "generic_name": "Iodixanol", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Visipaque", "active_ingredients": [{"name": "IODIXANOL", "strength": "320 mg/mL"}], "application_number": "NDA020351", "marketing_category": "NDA", "marketing_start_date": "20030909", "listing_expiration_date": "20261231"}