NDC 0407-1412
OMNIPAQUE
Iohexol
OMNIPAQUE is a Intrathecal; Intravascular; Intravenous; Oral Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Ge Healthcare Inc.. The primary component is Iohexol.
| Product ID | 0407-1412_139bf586-5a7e-41fc-8d29-df0c15a326be |
| NDC | 0407-1412 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OMNIPAQUE |
| Generic Name | Iohexol |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRATHECAL; INTRAVASCULAR; INTRAVENOUS; ORAL |
| Marketing Start Date | 2005-08-11 |
| Marketing Category | NDA / NDA |
| Application Number | NDA018956 |
| Labeler Name | GE Healthcare Inc. |
| Substance Name | IOHEXOL |
| Active Ingredient Strength | 240 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 0407-1412-38
10 BOTTLE, PLASTIC in 1 BOX (0407-1412-38) > 50 mL in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2005-08-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-1412-27 [00407141227]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-33 [00407141233]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-90 [00407141290]
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 0407-1412-30 [00407141230]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-32 [00407141232]
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 0407-1412-34 [00407141234]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-91 [00407141291]
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 0407-1412-28 [00407141228]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-60 [00407141260]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-38 [00407141238]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-08-11 |
NDC 0407-1412-49 [00407141249]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-26 [00407141226]
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 0407-1412-35 [00407141235]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-10 [00407141210]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-29 [00407141229]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-39 [00407141239]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-08-11 |
NDC 0407-1412-20 [00407141220]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-40 [00407141240]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-08-11 |
NDC 0407-1412-84 [00407141284]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-08-11 |
NDC 0407-1412-50 [00407141250]
OMNIPAQUE INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1985-12-26 |
NDC 0407-1412-51 [00407141251]
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 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOHEXOL | 240 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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