Active ingredient
Iodixanol
5 finished FDA listings contain Iodixanol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IODIXANOL
- Dosage forms
- Injection, Solution
- Routes
- Intravascular
- Manufacturers / labelers
- 2
- Strengths listed
- 270 mg/ml · 320 mg/ml
- Brand names in FDA listings
- Visipaque
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 27729
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 020351 | GE HEALTHCARE | 1996-03-22 | 2 |
| NDA 020808 | GE HEALTHCARE | 1997-08-29 | 1 |
| ANDA 214271 | HENGRUI PHARMA | 2022-05-19 | 2 |
Official labeling on DailyMed
- VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] · version 17 · 2025-11-17
- VISIPAQUE (IODIXANOL) INJECTION, SOLUTION [GE HEALTHCARE INC.] · version 14 · 2025-11-17
- IODIXANOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2023-08-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.