NDC 0407-1401
OMNIPAQUE
Iohexol
OMNIPAQUE is a Intravascular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare Inc.. The primary component is Iohexol.
| Product ID | 0407-1401_1f744058-0ffe-4096-82c1-a665d90ef341 |
| NDC | 0407-1401 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OMNIPAQUE |
| Generic Name | Iohexol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVASCULAR; INTRAVENOUS |
| Marketing Start Date | 2004-05-25 |
| Marketing Category | NDA / NDA |
| Application Number | NDA018956 |
| Labeler Name | GE Healthcare Inc. |
| Substance Name | IOHEXOL |
| Active Ingredient Strength | 140 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 0407-1401-52
10 BOTTLE, PLASTIC in 1 BOX (0407-1401-52) > 50 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2004-05-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-1401-52 [00407140152]
OMNIPAQUE INJECTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-05-25 |
NDC 0407-1401-50 [00407140150]
OMNIPAQUE INJECTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-05-25 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1401-51 [00407140151]
OMNIPAQUE INJECTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-05-25 |
| Marketing End Date | 2010-10-14 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOHEXOL | 140 mg/mL |
OpenFDA Data
| SPL SET ID: | eee15ebe-d349-4497-acef-6abe7a8247fb |
| 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 "OMNIPAQUE" or generic name "Iohexol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0407-1401 | OMNIPAQUE | Iohexol |
| 0407-1411 | OMNIPAQUE | Iohexol |
| 0407-1412 | OMNIPAQUE | Iohexol |
| 0407-1413 | Omnipaque | Iohexol |
| 0407-1414 | Omnipaque | Iohexol |
| 0407-1415 | OMNIPAQUE | OMNIPAQUE |
| 0407-1416 | OMNIPAQUE | OMNIPAQUE |
Trademark Results [OMNIPAQUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNIPAQUE 73340246 1207823 Live/Registered |
Sterling Drug Inc. 1981-12-07 |
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