omnipaque

Generic: iohexol

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

Drug Facts

Product Profile

Brand Name omnipaque
Generic Name iohexol
Labeler ge healthcare inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRA-ARTICULAR INTRATHECAL INTRAVASCULAR INTRAVENOUS ORAL RECTAL
Active Ingredients

iohexol 240 mg/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 0407-1412
Product ID 0407-1412_5bd452ab-2645-4f2d-8f53-2e984ee231b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018956
Listing Expiration 2026-12-31
Marketing Start 1985-12-26

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 04071412
Hyphenated Format 0407-1412

Supplemental Identifiers

UNII
4419T9MX03
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 omnipaque (source: ndc)
Generic Name iohexol (source: ndc)
Application Number NDA018956 (source: ndc)
Routes
INTRA-ARTICULAR INTRATHECAL INTRAVASCULAR INTRAVENOUS ORAL RECTAL
source: ndc

Resolved Composition

Strengths
  • 240 mg/mL
source: ndc
Packaging
  • 10 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-30) / 50 mL in 1 BOTTLE, PLASTIC
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-33) / 100 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

0407-1412-10 10 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS 0407-1412-20 10 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS 0407-1412-30 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-30) / 50 mL in 1 BOTTLE, PLASTIC 0407-1412-33 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-33) / 100 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

iohexol (240 mg/mL)

Linked Drug Pages (1)

OMNIPAQUE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRATHECAL", "INTRAVASCULAR", "INTRAVENOUS", "ORAL", "RECTAL"], "spl_id": "5bd452ab-2645-4f2d-8f53-2e984ee231b4", "openfda": {"nui": ["N0000180185", "N0000010258"], "unii": ["4419T9MX03"], "spl_set_id": ["eee15ebe-d349-4497-acef-6abe7a8247fb"], "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 VIAL, GLASS in 1 BOX (0407-1412-10)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "0407-1412-10", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 VIAL, GLASS in 1 BOX (0407-1412-20)  / 20 mL in 1 VIAL, GLASS", "package_ndc": "0407-1412-20", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1412-30)  / 50 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1412-30", "marketing_start_date": "19851226"}, {"sample": false, "description": "10 BOTTLE, PLASTIC in 1 BOX (0407-1412-33)  / 100 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1412-33", "marketing_start_date": "19851226"}], "brand_name": "OMNIPAQUE", "product_id": "0407-1412_5bd452ab-2645-4f2d-8f53-2e984ee231b4", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0407-1412", "generic_name": "Iohexol", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OMNIPAQUE", "active_ingredients": [{"name": "IOHEXOL", "strength": "240 mg/mL"}], "application_number": "NDA018956", "marketing_category": "NDA", "marketing_start_date": "19851226", "listing_expiration_date": "20261231"}