NDC 0407-2222
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 | 0407-2222_0c342862-fe6c-4ce6-aee2-809b40ab377c |
| NDC | 0407-2222 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Visipaque |
| Generic Name | Iodixanol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVASCULAR |
| Marketing Start Date | 2002-12-13 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020351 |
| Labeler Name | GE Healthcare Inc. |
| Substance Name | IODIXANOL |
| Active Ingredient Strength | 270 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0407-2222-16
10 BOTTLE, PLASTIC in 1 BOX (0407-2222-16) > 50 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2002-12-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-2222-17 [00407222217]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
NDC 0407-2222-23 [00407222223]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-03-01 |
| Marketing End Date | 2017-08-18 |
NDC 0407-2222-01 [00407222201]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2015-11-15 |
NDC 0407-2222-02 [00407222202]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2015-08-25 |
NDC 0407-2222-50 [00407222250]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2010-04-29 |
NDC 0407-2222-19 [00407222219]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
NDC 0407-2222-24 [00407222224]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020808 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2009-03-01 |
| Marketing End Date | 2017-08-18 |
NDC 0407-2222-52 [00407222252]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2013-12-02 |
NDC 0407-2222-21 [00407222221]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
NDC 0407-2222-53 [00407222253]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2014-06-29 |
NDC 0407-2222-06 [00407222206]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2010-04-29 |
NDC 0407-2222-05 [00407222205]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2222-32 [00407222232]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2222-31 [00407222231]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2012-04-20 |
NDC 0407-2222-16 [00407222216]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
NDC 0407-2222-54 [00407222254]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2013-09-08 |
NDC 0407-2222-55 [00407222255]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2014-09-29 |
NDC 0407-2222-03 [00407222203]
Visipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-12-13 |
| Marketing End Date | 2015-10-24 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IODIXANOL | 270 mg/mL |
OpenFDA Data
| SPL SET ID: | e9d87b8c-7695-4c0f-8e81-000dedb5f66d |
| Manufacturer | |
| UNII |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
- 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.