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: | 65293-005-11 |
Package Description: | 10 CARTON in 1 CARTON (65293-005-11) > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-00) > 100 mL in 1 VIAL, SINGLE-USE |
NDC Code | 65293-005-11 |
Proprietary Name | Cleviprex |
Package Description | 10 CARTON in 1 CARTON (65293-005-11) > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-00) > 100 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] |