NDC 0407-1414
Omnipaque
Iohexol
Omnipaque is a 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 | 0407-1414_064ef67f-cbc0-420d-8bdf-8dbcc5c728bc |
| NDC | 0407-1414 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Omnipaque |
| Generic Name | Iohexol |
| Dosage Form | Injection, Solution |
| Route of Administration | 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 | 350 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 0407-1414-98
10 BOTTLE, PLASTIC in 1 BOX (0407-1414-98) > 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 0407-1414-43 [00407141443]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-23 [00407141423]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-52 [00407141452]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-45 [00407141445]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-41 [00407141441]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-80 [00407141480]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-31 [00407141431]
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 0407-1414-72 [00407141472]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-12-21 |
NDC 0407-1414-84 [00407141484]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-90 [00407141490]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-26 [00407141426]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1414-21 [00407141421]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-85 [00407141485]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-04 [00407141404]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-20 [00407141420]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-93 [00407141493]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-22 [00407141422]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-24 [00407141424]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-36 [00407141436]
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 0407-1414-42 [00407141442]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-98 [00407141498]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2004-09-03 |
NDC 0407-1414-25 [00407141425]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2004-09-03 |
| Marketing End Date | 2018-11-30 |
NDC 0407-1414-76 [00407141476]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-94 [00407141494]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-60 [00407141460]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-50 [00407141450]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-89 [00407141489]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-44 [00407141444]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-03 [00407141403]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-87 [00407141487]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-86 [00407141486]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-53 [00407141453]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-48 [00407141448]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-12-21 |
NDC 0407-1414-51 [00407141451]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1414-88 [00407141488]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-08-03 |
NDC 0407-1414-37 [00407141437]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
| Marketing End Date | 2010-10-14 |
NDC 0407-1414-82 [00407141482]
Omnipaque INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-07-21 |
NDC 0407-1414-91 [00407141491]
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 | 350 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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