NDC 50419-320
EOVIST
Gadoxetate Disodium
EOVIST is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Gadoxetate Disodium.
| Product ID | 50419-320_1ff9281c-b174-4ce5-8116-b281fe3d2d99 |
| NDC | 50419-320 |
| Product Type | Human Prescription Drug |
| Proprietary Name | EOVIST |
| Generic Name | Gadoxetate Disodium |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2008-07-03 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022090 |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | GADOXETATE DISODIUM |
| Active Ingredient Strength | 181 mg/mL |
| Pharm Classes | Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 50419-320-05
5 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) > 10 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2008-07-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-320-05 [50419032005]
EOVIST INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022090 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2008-07-03 |
NDC 50419-320-75 [50419032075]
EOVIST INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022090 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2008-07-03 |
NDC 50419-320-01 [50419032001]
EOVIST INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022090 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2008-07-03 |
| Marketing End Date | 2010-08-03 |
NDC 50419-320-15 [50419032015]
EOVIST INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022090 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2008-07-03 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADOXETATE DISODIUM | 181.43 mg/mL |
OpenFDA Data
| SPL SET ID: | 6218b1e1-cbc3-4c14-bec7-528ac163a561 |
| Manufacturer | |
| UNII |
Pharmacological Class
- Gadolinium-based Contrast Agent [EPC]
- Magnetic Resonance Contrast Activity [MoA]
Trademark Results [EOVIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EOVIST 76358237 2758129 Live/Registered |
BAYER INTELLECTUAL PROPERTY GMBH 2002-01-14 |
 EOVIST 74668016 not registered Dead/Abandoned |
Schering Aktiengesellschaft 1995-05-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.