NDC 50419-325
Gadavist
Gadobutrol
Gadavist is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Gadobutrol.
| Product ID | 50419-325_013e6a9e-d632-4b80-bce8-d10ef3157033 |
| NDC | 50419-325 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gadavist |
| Generic Name | Gadobutrol |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2011-03-14 |
| Marketing Category | NDA / NDA |
| Application Number | NDA201277 |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | GADOBUTROL |
| Active Ingredient Strength | 605 mg/mL |
| Pharm Classes | Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 50419-325-18
2 CARTON in 1 BOX (50419-325-18) > 5 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS
| Marketing Start Date | 2011-03-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-325-29 [50419032529]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-91 [50419032591]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-03-14 |
| Marketing End Date | 2011-03-25 |
NDC 50419-325-12 [50419032512]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-92 [50419032592]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-03-14 |
| Marketing End Date | 2011-03-25 |
NDC 50419-325-28 [50419032528]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-90 [50419032590]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-03-14 |
| Marketing End Date | 2011-03-25 |
NDC 50419-325-14 [50419032514]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-27 [50419032527]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-72 [50419032572]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-15 [50419032515]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-13 [50419032513]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-11 [50419032511]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
NDC 50419-325-37 [50419032537]
Gadavist INJECTION
| Marketing Category | NDA |
| Application Number | NDA201277 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-03-15 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADOBUTROL | 604.72 mg/mL |
OpenFDA Data
| SPL SET ID: | bd28560f-de4d-4140-874e-31df823f4dbb |
| Manufacturer | |
| UNII |
Pharmacological Class
- Gadolinium-based Contrast Agent [EPC]
- Magnetic Resonance Contrast Activity [MoA]
Trademark Results [Gadavist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GADAVIST 85239263 4132896 Live/Registered |
BAYER INTELLECTUAL PROPERTY GMBH 2011-02-10 |
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