NDC 50419-188
Magnevist
Gadopentetate Dimeglumine
Magnevist is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Bayer Healthcare Pharmaceuticals Inc.. The primary component is Gadopentetate Dimeglumine.
| Product ID | 50419-188_010f5383-4b59-426a-aa4f-674079edb44c |
| NDC | 50419-188 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Magnevist |
| Generic Name | Gadopentetate Dimeglumine |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2022-05-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021037 |
| Labeler Name | Bayer HealthCare Pharmaceuticals Inc. |
| Substance Name | GADOPENTETATE DIMEGLUMINE |
| Active Ingredient Strength | 469 mg/mL |
| NDC Exclude Flag | N |
Packaging
NDC 50419-188-11
10 VIAL, PHARMACY BULK PACKAGE in 1 BOX (50419-188-11) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2022-05-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50419-188-58 [50419018858]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2022-05-30 |
NDC 50419-188-82 [50419018882]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-06-01 |
| Marketing End Date | 2022-01-31 |
NDC 50419-188-47 [50419018847]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-10-30 |
NDC 50419-188-44 [50419018844]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-07-31 |
NDC 50419-188-48 [50419018848]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2010-12-15 |
NDC 50419-188-10 [50419018810]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2009-08-23 |
NDC 50419-188-11 [50419018811]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2022-05-30 |
NDC 50419-188-42 [50419018842]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-01-31 |
NDC 50419-188-01 [50419018801]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-01-31 |
NDC 50419-188-84 [50419018884]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-06-01 |
| Marketing End Date | 2022-01-31 |
NDC 50419-188-05 [50419018805]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-07-31 |
NDC 50419-188-02 [50419018802]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-01-31 |
NDC 50419-188-36 [50419018836]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-02-28 |
NDC 50419-188-49 [50419018849]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2010-12-14 |
| Marketing End Date | 2010-12-15 |
NDC 50419-188-38 [50419018838]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-10-30 |
NDC 50419-188-46 [50419018846]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-01-31 |
NDC 50419-188-15 [50419018815]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-07-31 |
NDC 50419-188-81 [50419018881]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-06-01 |
| Marketing End Date | 2022-07-31 |
NDC 50419-188-40 [50419018840]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-07-31 |
NDC 50419-188-43 [50419018843]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2022-02-28 |
NDC 50419-188-37 [50419018837]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2023-01-31 |
NDC 50419-188-45 [50419018845]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-06-11 |
| Marketing End Date | 2023-01-31 |
NDC 50419-188-83 [50419018883]
Magnevist INJECTION
| Marketing Category | NDA |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2016-06-01 |
| Marketing End Date | 2022-07-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADOPENTETATE DIMEGLUMINE | 469.01 mg/mL |
OpenFDA Data
| SPL SET ID: | abef9e9b-a29f-4abe-aeff-88ae42648057 |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "Magnevist" or generic name "Gadopentetate Dimeglumine"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50419-188 | Magnevist | gadopentetate dimeglumine |
| 47781-147 | Gadopentetate dimeglumine | Gadopentetate dimeglumine |
Trademark Results [Magnevist]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAGNEVIST 74186321 1797473 Live/Registered |
BAYER HEALTHCARE LLC 1991-07-18 |
 MAGNEVIST 73555552 1413925 Live/Registered |
BERLEX LABORATORIES, INC. 1985-08-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.