| Product NDC: | 0019-1177 |
| Proprietary Name: | OPTIMARK |
| Non Proprietary Name: | GADOVERSETAMIDE |
| Active Ingredient(s): | .5 mmol/mL & nbsp; GADOVERSETAMIDE |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0019-1177 |
| Labeler Name: | Mallinckrodt Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020975 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20101210 |
| Package NDC: | 0019-1177-04 |
| Package Description: | 10 VIAL, GLASS in 1 CARTON (0019-1177-04) > 10 mL in 1 VIAL, GLASS |
| NDC Code | 0019-1177-04 |
| Proprietary Name | OPTIMARK |
| Package Description | 10 VIAL, GLASS in 1 CARTON (0019-1177-04) > 10 mL in 1 VIAL, GLASS |
| Product NDC | 0019-1177 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | GADOVERSETAMIDE |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20101210 |
| Marketing Category Name | NDA |
| Labeler Name | Mallinckrodt Inc. |
| Substance Name | GADOVERSETAMIDE |
| Strength Number | .5 |
| Strength Unit | mmol/mL |
| Pharmaceutical Classes |