NDC 0407-1412 – Omnipaque
Iohexol 240 mg/mL · Injection, Solution · Intra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal
Product NDC0407-1412
Product details
- Brand name
- Omnipaque
- Generic name
- Iohexol
- Labeler
- GE Healthcare Inc.
- Dosage form
- Injection, Solution
- Route
- Intra-articular, Intrathecal, Intravascular, Intravenous, Oral, Rectal
- Marketing category
- NDA · NDA018956
- Marketed since
- December 26, 1985
- Listing expires
- December 31, 2027
- Pharmacologic class
- Radiographic Contrast Agent
Active ingredients
- Iohexol 240 mg/mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 0407-1412-10 | 10 VIAL, GLASS in 1 BOX (0407-1412-10) / 10 mL in 1 VIAL, GLASS | Dec 26, 1985 |
| 0407-1412-20 | 10 VIAL, GLASS in 1 BOX (0407-1412-20) / 20 mL in 1 VIAL, GLASS | Dec 26, 1985 |
| 0407-1412-30 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-30) / 50 mL in 1 BOTTLE, PLASTIC | Dec 26, 1985 |
| 0407-1412-33 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1412-33) / 100 mL in 1 BOTTLE, PLASTIC | Dec 26, 1985 |
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
- 0407-1401 Iohexol 140 mg/mL · Injection, Solution · GE Healthcare Inc.
- 0407-1411 Iohexol 180 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.
- 0407-1415 Iohexol 9 mg/mL · Solution · GE Healthcare Inc.
- 0407-1416 Iohexol 12 mg/mL · 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