| Product NDC: | 65293-005 |
| Proprietary Name: | Cleviprex |
| Non Proprietary Name: | clevidipine |
| Active Ingredient(s): | .5 mg/mL & nbsp; clevidipine |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | EMULSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 65293-005 |
| Labeler Name: | The Medicines Company |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022156 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080915 |
| Package NDC: | 65293-005-55 |
| Package Description: | 10 CARTON in 1 CARTON (65293-005-55) > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-50) > 50 mL in 1 VIAL, SINGLE-USE |
| NDC Code | 65293-005-55 |
| Proprietary Name | Cleviprex |
| Package Description | 10 CARTON in 1 CARTON (65293-005-55) > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-50) > 50 mL in 1 VIAL, SINGLE-USE |
| Product NDC | 65293-005 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | clevidipine |
| Dosage Form Name | EMULSION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20080915 |
| Marketing Category Name | NDA |
| Labeler Name | The Medicines Company |
| Substance Name | CLEVIDIPINE |
| Strength Number | .5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [Chemical/Ingredient] |