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OMNIPAQUE

Iohexol · Solution

Prescription NDA TE AP RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
OMNIPAQUE
Generic name
Iohexol
Dosage form
Solution
Route
Oral
Marketing category
NDA · NDA
Labeler
GE Healthcare Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Iohexol 12 mg/mL — View
Iohexol 9 mg/mL — View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Solution
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Radiographic Contrast Agent [EPC] EPC All 19 members
X-Ray Contrast Activity [MoA] MoA All 19 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
018956
Application type
NDA · New Drug Application
Approval date
December 26, 1985
Sponsor
GE HEALTHCARE
Products on application
9
Submissions recorded
68
Products approved under application 018956.
Product Trade name Form Strength Ingredient Status TE Flags
018956-001 OMNIPAQUE 180 SOLUTION IOHEXOL Prescription — RLD RS
018956-002 OMNIPAQUE 240 SOLUTION IOHEXOL Prescription — RLD RS
018956-003 OMNIPAQUE 300 SOLUTION IOHEXOL Prescription AP RLD RS
018956-004 OMNIPAQUE 350 SOLUTION IOHEXOL Prescription AP RLD RS
018956-005 OMNIPAQUE 140 INJECTABLE IOHEXOL Prescription — RLD RS
018956-006 OMNIPAQUE 210 INJECTABLE IOHEXOL Discontinued —
018956-007 OMNIPAQUE 70 SOLUTION IOHEXOL Discontinued —
018956-008 OMNIPAQUE 9 SOLUTION IOHEXOL Prescription — RLD RS
018956-009 OMNIPAQUE 12 SOLUTION IOHEXOL Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 018956.
Type No. Action Status Date Review
Supplement 119 Labeling Approved October 8, 2024 Standard
Supplement 116 Labeling Approved April 25, 2023 Standard
Supplement 113 Labeling Approved February 18, 2022 Standard
Supplement 112 Labeling Approved August 5, 2021 Standard
Supplement 108 Labeling Approved November 4, 2020 Standard
Supplement 105 Labeling Approved July 2, 2020 Standard
Supplement 101 Labeling Approved April 17, 2018 Standard
Supplement 99 Labeling Approved April 5, 2017 Standard
Supplement 96 Manufacturing (CMC) Approved October 21, 2015 Standard
Supplement 95 Labeling Approved July 6, 2015 Standard
Supplement 94 Manufacturing (CMC) Approved March 3, 2015 Standard
Supplement 93 Manufacturing (CMC) Approved June 19, 2014 Standard
Supplement 91 Manufacturing (CMC) Approved February 10, 2014 Standard
Supplement 92 Manufacturing (CMC) Approved November 20, 2013 Standard
Supplement 89 Manufacturing (CMC) Approved August 21, 2013 Standard
Supplement 76 Labeling Approved October 1, 2007 Standard
Supplement 65 Manufacturing (CMC) Approved March 25, 2005 Standard
Supplement 62 Labeling Approved December 27, 2004 Standard
Supplement 58 Labeling Approved March 5, 2004 Standard
Supplement 49 Labeling Approved December 23, 2002 Standard
Supplement 39 Labeling Approved December 23, 2002 —
Supplement 54 Manufacturing (CMC) Approved November 20, 2002 Standard
Supplement 53 Manufacturing (CMC) Approved August 5, 2002 Standard
Supplement 52 Manufacturing (CMC) Approved December 19, 2000 Standard
Supplement 51 Manufacturing (CMC) Approved September 8, 1998 Standard
Supplement 30 Manufacturing (CMC) Approved December 4, 1995 Standard
Supplement 42 Manufacturing (CMC) Approved November 28, 1995 Standard
Supplement 46 Manufacturing (CMC) Approved August 18, 1995 Standard
Supplement 44 Manufacturing (CMC) Approved August 18, 1995 Standard
Supplement 43 Labeling Approved June 15, 1995 Standard
Supplement 45 Manufacturing (CMC) Approved November 4, 1994 Standard
Supplement 41 Manufacturing (CMC) Approved September 30, 1994 Standard
Supplement 36 Labeling Approved June 1, 1994 —
Supplement 35 Manufacturing (CMC) Approved June 1, 1994 Standard
Supplement 8 Manufacturing (CMC) Approved December 23, 1993 Standard
Supplement 28 Efficacy Approved July 13, 1993 —
Supplement 34 Manufacturing (CMC) Approved March 1, 1993 Standard
Supplement 33 Labeling Approved March 1, 1993 —
Supplement 32 Manufacturing (CMC) Approved March 1, 1993 Standard
Supplement 31 Manufacturing (CMC) Approved March 1, 1993 Standard
Supplement 37 Manufacturing (CMC) Approved December 11, 1992 Standard
Supplement 40 Manufacturing (CMC) Approved October 20, 1992 Standard
Supplement 38 Manufacturing (CMC) Approved September 30, 1992 Standard
Supplement 27 Manufacturing (CMC) Approved March 26, 1992 Standard
Supplement 29 Manufacturing (CMC) Approved August 24, 1990 Standard
Supplement 26 Efficacy Approved November 30, 1989 —
Supplement 23 Efficacy Approved July 28, 1989 —
Supplement 22 Efficacy Approved July 28, 1989 —
Supplement 21 Efficacy Approved June 30, 1989 —
Supplement 20 Efficacy Approved June 30, 1989 —
Supplement 10 Manufacturing (CMC) Approved May 22, 1989 Standard
Supplement 24 Labeling Approved May 3, 1989 —
Supplement 18 Efficacy Approved March 31, 1989 —
Supplement 19 Manufacturing (CMC) Approved January 4, 1989 Standard
Supplement 17 Efficacy Approved November 30, 1988 —
Supplement 14 Efficacy Approved July 29, 1988 —
Supplement 15 Efficacy Approved May 24, 1988 —
Supplement 16 Manufacturing (CMC) Approved April 18, 1988 Standard
Supplement 12 Efficacy Approved February 1, 1988 —
Supplement 13 Manufacturing (CMC) Approved January 27, 1988 Standard

Review documents

  • 0 · Supplement · October 10, 2024
  • 0 · Supplement · October 9, 2024
  • 0 · Supplement · April 27, 2023
  • 0 · Supplement · April 27, 2023
  • 0 · Supplement · February 25, 2022
  • 0 · Supplement · February 22, 2022
  • 0 · Supplement · August 6, 2021
  • 0 · Supplement · August 6, 2021
  • 0 · Supplement · January 25, 2021
  • 0 · Supplement · November 5, 2020
  • 0 · Supplement · July 6, 2020
  • 0 · Supplement · July 6, 2020
  • 0 · Supplement · April 20, 2018
  • 0 · Supplement · April 19, 2018
  • 0 · Supplement · April 12, 2017
  • 0 · Supplement · April 7, 2017
  • 0 · Supplement · July 10, 2015
  • 0 · Supplement · July 9, 2015
  • 0 · Supplement · October 4, 2007
  • 0 · Supplement · March 30, 2005
  • 0 · Supplement · December 29, 2004
  • 0 · Supplement · March 10, 2004
  • 0 · Supplement · August 5, 2003
  • 0 · Supplement · December 23, 2002
  • 0 · Supplement · December 23, 2002
  • 0 · Supplement · May 11, 1998

Adverse event reports

Source: openFDA FAERS
8,244
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IOHEXOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0407-1415-09 0407-1415 GE Healthcare Inc. 10 BOTTLE, PLASTIC in 1 BOX (0407-1415-09) / 500 mL in 1 BOTTLE, PLASTIC April 27, 2018
0407-1416-12 0407-1416 GE Healthcare Inc. 10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC April 27, 2018
0407-1415 0407-1415 GE Healthcare Inc. — April 27, 2018
0407-1416 0407-1416 GE Healthcare Inc. — April 27, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.