Gadopentetate dimeglumine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Alvogen, Inc. The primary component is Gadopentetate Dimeglumine.
| Product ID | 47781-147_1d137c2c-fd59-4203-8115-b0a25a282bef |
| NDC | 47781-147 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gadopentetate dimeglumine |
| Generic Name | Gadopentetate Dimeglumine |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2014-02-24 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA019596 |
| Labeler Name | Alvogen, Inc |
| Substance Name | GADOPENTETATE DIMEGLUMINE |
| Active Ingredient Strength | 469 mg/mL |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2014-02-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-02-24 |
| Marketing End Date | 2020-01-16 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-02-24 |
| Marketing End Date | 2020-01-16 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-02-24 |
| Marketing End Date | 2020-01-16 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-02-24 |
| Marketing End Date | 2020-01-16 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019596 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-02-24 |
| Marketing End Date | 2020-01-16 |
| Marketing Category | NDA authorized generic |
| Application Number | NDA021037 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2014-02-24 |
| Marketing End Date | 2020-01-16 |
| Ingredient | Strength |
|---|---|
| GADOPENTETATE DIMEGLUMINE | 469.01 mg/mL |
| SPL SET ID: | 25c782d4-7b45-4437-b80c-54271e3831b9 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 47781-147 | Gadopentetate dimeglumine | Gadopentetate dimeglumine |
| 50419-188 | Magnevist | gadopentetate dimeglumine |