NDC 0407-2223
Visipaque
Iodixanol
Visipaque is a Intravascular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare Inc.. The primary component is Iodixanol.
| Product ID | 0407-2223_0a22bcdf-5055-4a51-a515-65926207ccb4 |
| NDC | 0407-2223 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Visipaque |
| Generic Name | Iodixanol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVASCULAR |
| Marketing Start Date | 2010-06-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020351 |
| Labeler Name | GE Healthcare Inc. |
| Substance Name | IODIXANOL |
| Active Ingredient Strength | 320 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 0407-2223-62
10 BOTTLE, PLASTIC in 1 BOX (0407-2223-62) > 50 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2010-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-2223-61 [00407222361]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
| Marketing End Date | 2015-05-21 |
NDC 0407-2223-17 [00407222317]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
NDC 0407-2223-03 [00407222303]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2015-11-29 |
NDC 0407-2223-05 [00407222305]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2223-16 [00407222316]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
NDC 0407-2223-67 [00407222367]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-2223-56 [00407222356]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2019-04-11 |
NDC 0407-2223-02 [00407222302]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
NDC 0407-2223-34 [00407222334]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2223-54 [00407222354]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2019-04-12 |
NDC 0407-2223-23 [00407222323]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-05-01 |
NDC 0407-2223-35 [00407222335]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2223-04 [00407222304]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2015-10-10 |
NDC 0407-2223-63 [00407222363]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
| Marketing End Date | 2015-05-21 |
NDC 0407-2223-55 [00407222355]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2018-07-28 |
NDC 0407-2223-06 [00407222306]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2016-01-24 |
NDC 0407-2223-66 [00407222366]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-2223-21 [00407222321]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
NDC 0407-2223-62 [00407222362]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-2223-57 [00407222357]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2019-03-25 |
NDC 0407-2223-65 [00407222365]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
| Marketing End Date | 2015-05-21 |
NDC 0407-2223-32 [00407222332]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2223-01 [00407222301]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2015-12-14 |
NDC 0407-2223-19 [00407222319]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2003-09-09 |
NDC 0407-2223-50 [00407222350]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2015-11-29 |
NDC 0407-2223-64 [00407222364]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-2223-53 [00407222353]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2015-08-31 |
NDC 0407-2223-58 [00407222358]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-05-01 |
| Marketing End Date | 2017-08-18 |
NDC 0407-2223-30 [00407222330]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2223-51 [00407222351]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-09-09 |
| Marketing End Date | 2015-09-26 |
NDC 0407-2223-60 [00407222360]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
| Marketing End Date | 2015-05-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IODIXANOL | 320 mg/mL |
OpenFDA Data
| SPL SET ID: | 952d0aa5-6dfd-49cc-8476-b781e5c7b86c |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
NDC Crossover Matching brand name "Visipaque" or generic name "Iodixanol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0407-2222 | Visipaque | Iodixanol |
| 0407-2223 | Visipaque | Iodixanol |
| 65219-381 | Iodixanol | Iodixanol |
| 65219-383 | Iodixanol | Iodixanol |
Trademark Results [Visipaque]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISIPAQUE 74448170 not registered Dead/Abandoned |
Sterling Winthrop Inc. 1993-10-18 |
 VISIPAQUE 74085163 1726942 Live/Registered |
GE HEALTHCARE AS 1990-08-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.