Search by Drug Name or NDC
NDC 65219-0383-05 Iodixanol 320 mg/mL Details
Iodixanol 320 mg/mL
Iodixanol is a INTRAVASCULAR INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by FRESENIUS KABI USA, LLC. The primary component is IODIXANOL.
Product Information
| NDC | 65219-0383 |
|---|---|
| Product ID | 65219-383_1980ecbd-58c9-4176-af7f-af955bb0ad2e |
| Associated GPIs | |
| GCN Sequence Number | 027416 |
| GCN Sequence Number Description | iodixanol INFUS. BTL 320 MG/ML INTRAVEN |
| HIC3 | A6U |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS-RADIOPAQUE |
| GCN | 46861 |
| HICL Sequence Number | 011569 |
| HICL Sequence Number Description | IODIXANOL |
| Brand/Generic | Generic |
| Proprietary Name | Iodixanol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Iodixanol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVASCULAR |
| Active Ingredient Strength | 320 |
| Active Ingredient Units | mg/mL |
| Substance Name | IODIXANOL |
| Labeler Name | FRESENIUS KABI USA, LLC |
| Pharmaceutical Class | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214271 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65219-0383-05 (65219038305)
| NDC Package Code | 65219-383-05 |
|---|---|
| Billing NDC | 65219038305 |
| Package | 10 BOTTLE, PLASTIC in 1 BOX (65219-383-05) / 50 mL in 1 BOTTLE, PLASTIC (65219-383-02) |
| Marketing Start Date | 2022-06-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |