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Gadavist
Gadavist - 50419-325-11 - (gadobutrol)
Drug Information of Gadavist
| 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) |
Labeler Information of Gadavist
| 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 Information of Gadavist
| Package NDC: | 50419-325-11 |
| Package Description: | 2 CARTON in 1 BOX (50419-325-11) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 7.5 mL in 1 VIAL, SINGLE-DOSE |
NDC Information of Gadavist
| NDC Code | 50419-325-11 |
| Proprietary Name | Gadavist |
| Package Description | 2 CARTON in 1 BOX (50419-325-11) > 10 VIAL, SINGLE-DOSE in 1 CARTON > 7.5 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 |
