Iodixanol
- Product NDC
- 65219-381
- 11-digit product format
- 652190381
- Labeler code
- 65219
- Product ID
- 65219-381_1980ecbd-58c9-4176-af7f-af955bb0ad2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Iodixanol
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVASCULAR
- Labeler
- FRESENIUS KABI USA, LLC
- Application
- ANDA214271
- Marketing category
- ANDA
- Marketing start
- 2022-06-21
- Substance
- IODIXANOL
- Active strength
- 270 mg/mL
- Pharmacologic classes
- Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Iodixanol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IODIXANOL | 270 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HW8W27HTXX |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-381-03 | Iodixanol | 100 mL in 1 BOTTLE, PLASTIC | INJECTION, SOLUTION | 100 | | 5 |
| 65219-381-05 | Iodixanol | 150 mL in 1 BOTTLE, PLASTIC | INJECTION, SOLUTION | 150 | | 5 |
| 65219-381-10 | Iodixanol | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 5 |
| 65219-381-50 | Iodixanol | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-381 | IODIXANOL INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230803_0fe89ea2-04f7-46c5-9c35-220d8c144a95.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-381-03 | 65219038103 | 100 mL in 1 BOTTLE, PLASTIC | 100 ml | | | | | Historical |
| 65219-381-05 | 65219038105 | 150 mL in 1 BOTTLE, PLASTIC | 150 ml | | | | | Historical |
| 65219-381-10 | 65219038110 | 10 BOTTLE, PLASTIC in 1 BOX (65219-381-10) / 100 mL in 1 BOTTLE, PLASTIC (65219-381-03) | | 2022-06-21 | 0000-00-00 | No | No | Current |
| 65219-381-50 | 65219038150 | 10 BOTTLE, PLASTIC in 1 BOX (65219-381-50) / 150 mL in 1 BOTTLE, PLASTIC (65219-381-05) | | 2022-06-21 | 0000-00-00 | No | No | Current |