NDC 10122-612

Cleviprex

Clevipidine

Cleviprex is a Intravenous Emulsion in the Human Prescription Drug category. It is labeled and distributed by Chiesi Usa, Inc.. The primary component is Clevidipine.

• Product ID: 10122-612_04948b75-fd66-48df-8b8b-8930c1ec5de5
• NDC: 10122-612
• Product Type: Human Prescription Drug
• Proprietary Name: Cleviprex
• Generic Name: Clevipidine
• Dosage Form: Emulsion
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-09-15
• Marketing Category: NDA / NDA
• Application Number: NDA022156
• Labeler Name: Chiesi USA, Inc.
• 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: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 10122-612-04

4 CARTON in 1 CARTON (10122-612-04) > 1 VIAL, SINGLE-USE in 1 CARTON (10122-612-01) > 250 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 10122-612-04 [10122061204]

Cleviprex EMULSION

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

NDC 10122-612-01 [10122061201]

Cleviprex EMULSION

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

Drug Details

Active Ingredients

Ingredient	Strength
CLEVIDIPINE	.5 mg/mL

OpenFDA Data

• SPL SET ID: f9290625-b723-4eda-bab8-a97bef6041f6
• Manufacturer:
  • Chiesi USA, Inc.
• 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 "Clevipidine"

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