Product NDC: | 50419-325 |
Proprietary Name: | Gadavist |
Non Proprietary Name: | gadobutrol |
Active Ingredient(s): | 604.72 mg/mL & nbsp; gadobutrol |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50419-325 |
Labeler Name: | Bayer HealthCare Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA201277 |
Marketing Category: | NDA |
Start Marketing Date: | 20110314 |
Package NDC: | 50419-325-12 |
Package Description: | 2 CARTON in 1 BOX (50419-325-12) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 50419-325-12 |
Proprietary Name | Gadavist |
Package Description | 2 CARTON in 1 BOX (50419-325-12) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 10 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 50419-325 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | gadobutrol |
Dosage Form Name | INJECTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20110314 |
Marketing Category Name | NDA |
Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
Substance Name | GADOBUTROL |
Strength Number | 604.72 |
Strength Unit | mg/mL |
Pharmaceutical Classes |