NDC 0407-1413
Omnipaque
Iohexol
Omnipaque is a Intrathecal; Intravascular; Intravenous; Oral; Rectal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare Inc.. The primary component is Iohexol.
| Product ID | 0407-1413_064ef67f-cbc0-420d-8bdf-8dbcc5c728bc |
| NDC | 0407-1413 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Omnipaque |
| Generic Name | Iohexol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL; RECTAL |
| Marketing Start Date | 2004-09-03 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020608 |
| Labeler Name | GE Healthcare Inc. |
| Substance Name | IOHEXOL |
| Active Ingredient Strength | 300 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 0407-1413-68
10 BOTTLE, PLASTIC in 1 BOX (0407-1413-68) > 500 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2004-09-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-1413-90 [00407141390]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-68 [00407141368]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-09-03 |
NDC 0407-1413-75 [00407141375]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1413-76 [00407141376]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1413-41 [00407141341]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-92 [00407141392]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-47 [00407141347]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-94 [00407141394]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-09-03 |
| Marketing End Date | 2019-04-01 |
NDC 0407-1413-96 [00407141396]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-42 [00407141342]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-98 [00407141398]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-72 [00407141372]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-74 [00407141374]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1413-53 [00407141353]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-62 [00407141362]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-50 [00407141350]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-59 [00407141359]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-95 [00407141395]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-30 [00407141330]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-48 [00407141348]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-12-21 |
NDC 0407-1413-10 [00407141310]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-89 [00407141389]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-08-03 |
NDC 0407-1413-61 [00407141361]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-11 [00407141311]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-25 [00407141325]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1413-60 [00407141360]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-66 [00407141366]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-88 [00407141388]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-46 [00407141346]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-91 [00407141391]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-86 [00407141386]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-65 [00407141365]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-43 [00407141343]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-63 [00407141363]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-55 [00407141355]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-09-03 |
| Marketing End Date | 2013-01-29 |
NDC 0407-1413-87 [00407141387]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-1413-99 [00407141399]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-71 [00407141371]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2009-11-04 |
NDC 0407-1413-93 [00407141393]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1413-51 [00407141351]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOHEXOL | 300 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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