NDC 65293-005

Cleviprex

Clevidipine

Cleviprex is a Intravenous Emulsion in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Clevidipine.

• Product ID: 65293-005_c8c2dc00-90a3-11e4-b4a9-0800200c9a66
• NDC: 65293-005
• Product Type: Human Prescription Drug
• Proprietary Name: Cleviprex
• Generic Name: Clevidipine
• Dosage Form: Emulsion
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-09-15
• Marketing Category: NDA / NDA
• Application Number: NDA022156
• Labeler Name: The Medicines Company
• Substance Name: CLEVIDIPINE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 65293-005-55

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

• Marketing Start Date: 2008-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65293-005-55 [65293000555]

Cleviprex EMULSION

• Marketing Category: NDA
• Application Number: NDA022156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-09-15
• Marketing End Date: 2018-08-31

NDC 65293-005-25 [65293000525]

Cleviprex EMULSION

• Marketing Category: NDA
• Application Number: NDA022156
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-12-31
• Marketing End Date: 2018-08-31

NDC 65293-005-11 [65293000511]

Cleviprex EMULSION

• Marketing Category: NDA
• Application Number: NDA022156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-09-15
• Marketing End Date: 2018-08-31

NDC 65293-005-00 [65293000500]

Cleviprex EMULSION

• Marketing Category: NDA
• Application Number: NDA022156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-09-15
• Marketing End Date: 2018-08-31

NDC 65293-005-50 [65293000550]

Cleviprex EMULSION

• Marketing Category: NDA
• Application Number: NDA022156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-09-15
• Marketing End Date: 2018-08-31

NDC 65293-005-04 [65293000504]

Cleviprex EMULSION

• Marketing Category: NDA
• Application Number: NDA022156
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-09-15
• Marketing End Date: 2018-08-31

Drug Details

Active Ingredients

Ingredient	Strength
CLEVIDIPINE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 095081a0-1398-11dc-82e1-0002a5d5c51b
• Manufacturer:
  • The Medicines Company
• UNII:
  • 19O2GP3B7Q
• RxNorm Concept Unique ID - RxCUI:
  • 1790248
  • 1790245
  • 1790246
  • 1790247
  • 1790242
  • 1790239

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]

NDC Crossover Matching brand name "Cleviprex" or generic name "Clevidipine"

NDC	Brand Name	Generic Name
10122-610	Cleviprex	clevipidine
10122-611	Cleviprex	clevipidine
10122-612	Cleviprex	clevipidine
18124-011	Cleviprex	clevidipine
65293-005	Cleviprex	clevidipine