Active ingredient
Iopamidol
14 finished FDA listings contain Iopamidol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IOPAMIDOL
- Dosage forms
- Injection, Solution
- Routes
- Intrathecal, Intravascular
- Manufacturers / labelers
- 3
- Strengths listed
- 408 mg/ml · 510 mg/ml · 612 mg/ml · 755 mg/ml
- Brand names in FDA listings
- Isovue 200, Isovue 250, Isovue 300, Isovue 370, Isovue-M
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 5966
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 018735 | BRACCO | 1985-12-31 | 6 |
| NDA 020327 | BRACCO | 1994-10-12 | 2 |
| ANDA 215382 | HAINAN POLY | 2023-02-27 | 2 |
| ANDA 217134 | HAINAN POLY | 2023-09-27 | 4 |
Official labeling on DailyMed
- IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] · version 6 · 2026-08-04
- ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] · version 15 · 2026-04-20
- ISOVUE 300 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 370 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 200 (IOPAMIDOL) INJECTION, SOLUTION ISOVUE 250 (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] · version 22 · 2026-03-16
- ISOVUE-M (IOPAMIDOL) INJECTION, SOLUTION [BRACCO DIAGNOSTICS INC] · version 10 · 2026-02-13
- IOPAMIDOL INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] · version 3 · 2025-07-18
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.