NDC 0407-1415 – Omnipaque
Iohexol 9 mg/mL · Solution · Oral
Product NDC0407-1415
Product details
- Brand name
- Omnipaque
- Generic name
- Iohexol
- Labeler
- GE Healthcare Inc.
- Dosage form
- Solution
- Route
- Oral
- Marketing category
- NDA · NDA018956
- Marketed since
- April 27, 2018
- Listing expires
- December 31, 2027
- Pharmacologic class
- Radiographic Contrast Agent
Active ingredients
- Iohexol 9 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0407-1415-09 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1415-09) / 500 mL in 1 BOTTLE, PLASTIC | Apr 27, 2018 |
Recalls mentioning this NDC
- D-0448-2026 Apr 15, 2026 · Class II
Presence of particulate matter - D-0447-2026 Apr 15, 2026 · Class II
Presence of particulate matter - D-0319-2019 Dec 26, 2018 · Class II
Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Other Omnipaque products
- 0407-1416 Iohexol 12 mg/mL · Solution · GE Healthcare Inc.
- 0407-1401 Iohexol 140 mg/mL · Injection, Solution · GE Healthcare Inc.
- 0407-1411 Iohexol 180 mg/mL · Injection, Solution · GE Healthcare Inc.
- 0407-1412 Iohexol 240 mg/mL · Injection, Solution · GE Healthcare Inc.
- 0407-1413 Iohexol 300 mg/mL · Injection, Solution · GE Healthcare Inc.
- 0407-1414 Iohexol 350 mg/mL · Injection, Solution · GE Healthcare Inc.
- 71872-7369 Iohexol 240 mg/mL · Injection, Solution · Medical Purchasing Solutions, LLC
- 71872-7370 Iohexol 300 mg/mL · Injection, Solution · Medical Purchasing Solutions, LLC