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 SOLUTION
Routes
ORAL
Active Ingredients

iohexol 12 mg/mL

Manufacturer
GE Healthcare Inc.

Identifiers & Regulatory

Product NDC 0407-1416
Product ID 0407-1416_5bd452ab-2645-4f2d-8f53-2e984ee231b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018956
Listing Expiration 2026-12-31
Marketing Start 2018-04-27

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 04071416
Hyphenated Format 0407-1416

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
ORAL
source: ndc

Resolved Composition

Strengths
  • 12 mg/mL
source: ndc
Packaging
  • 10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0407-1416-12 10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

iohexol (12 mg/mL)

Linked Drug Pages (1)

OMNIPAQUE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "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 BOTTLE, PLASTIC in 1 BOX (0407-1416-12)  / 500 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0407-1416-12", "marketing_start_date": "20180427"}], "brand_name": "OMNIPAQUE", "product_id": "0407-1416_5bd452ab-2645-4f2d-8f53-2e984ee231b4", "dosage_form": "SOLUTION", "pharm_class": ["Radiographic Contrast Agent [EPC]", "X-Ray Contrast Activity [MoA]"], "product_ndc": "0407-1416", "generic_name": "Iohexol", "labeler_name": "GE Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OMNIPAQUE", "active_ingredients": [{"name": "IOHEXOL", "strength": "12 mg/mL"}], "application_number": "NDA018956", "marketing_category": "NDA", "marketing_start_date": "20180427", "listing_expiration_date": "20261231"}