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 |