| Product NDC: | 50419-320 |
| Proprietary Name: | EOVIST |
| Non Proprietary Name: | Gadoxetate Disodium |
| Active Ingredient(s): | 181.43 mg/mL & nbsp; Gadoxetate Disodium |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50419-320 |
| Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022090 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080703 |
| Package NDC: | 50419-320-05 |
| Package Description: | 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) > 10 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 50419-320-05 |
| Proprietary Name | EOVIST |
| Package Description | 5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) > 10 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 50419-320 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Gadoxetate Disodium |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20080703 |
| Marketing Category Name | NDA |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | GADOXETATE DISODIUM |
| Strength Number | 181.43 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes |