Active ingredient
Iohexol
17 finished FDA listings contain Iohexol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IOHEXOL
- Dosage forms
- Injection, Solution, Solution
- Routes
- Intra-Articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal
- Manufacturers / labelers
- 4
- Strengths listed
- 12 mg/ml · 140 mg/ml · 180 mg/ml · 240 mg/ml · 300 mg/ml · 350 mg/ml · 9 mg/ml
- Brand names in FDA listings
- Omnipaque
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5956
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018956 | GE HEALTHCARE | 1985-12-26 | 9 |
| NDA 020608 | GE HEALTHCARE | 1995-10-24 | 2 |
| ANDA 217737 | AMNEAL | 2025-11-13 | 6 |
Official labeling on DailyMed
- IOHEXOL INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] · version 11 · 2026-07-21
- OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] · version 1 · 2026-04-30
- OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC] · version 1 · 2026-04-30
- OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.] · version 19 · 2026-04-21
- OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION [GE HEALTHCARE] · version 13 · 2026-04-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.