OMNIPAQUE
- Product NDC
- 0407-1415
- 11-digit product format
- 004071415
- Labeler code
- 0407
- Product ID
- 0407-1415_61f3e388-89bf-43d6-ad51-b620fff561fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iohexol
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- GE Healthcare Inc.
- Application
- NDA018956
- Marketing category
- NDA
- Marketing start
- 2018-04-27
- Substance
- IOHEXOL
- Active strength
- 9 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OMNIPAQUE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IOHEXOL | 9 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4419T9MX03 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0407-1415-09 | OMNIPAQUE | 500 mL in 1 BOTTLE, PLASTIC | SOLUTION | 500 | | 19 |
| 0407-1415-09 | OMNIPAQUE | 10 in 1 BOX | SOLUTION | 10 | | 19 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0407-1415 | OMNIPAQUE (IOHEXOL) INJECTION, SOLUTION OMNIPAQUE (IOHEXOL) SOLUTION [GE HEALTHCARE INC.] | 18 | Current NDC, Legacy NDC, 2 package rows | 20241024_eee15ebe-d349-4497-acef-6abe7a8247fb.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0407-1415-09 | 00407141509 | 10 BOTTLE, PLASTIC in 1 BOX (0407-1415-09) / 500 mL in 1 BOTTLE, PLASTIC | 2018-04-27 | 0000-00-00 | No | No | Current |