NDC 18124-011

Cleviprex

Clevidipine

Cleviprex is a Intravenous Emulsion in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Austria Gmbh. The primary component is Clevidipine.

• Product ID: 18124-011_0ef540ec-3e55-44d0-b8b9-e70407a54748
• NDC: 18124-011
• 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: Fresenius Kabi Austria GmbH
• 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: 2023-12-31

Packaging

NDC 18124-011-00

10 CARTON in 1 CARTON (18124-011-00) > 1 VIAL, SINGLE-USE in 1 CARTON > 100 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 18124-011-50 [18124001150]

Cleviprex EMULSION

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

NDC 18124-011-00 [18124001100]

Cleviprex EMULSION

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

NDC 18124-011-25 [18124001125]

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: a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330
• Manufacturer:
  • Fresenius Kabi Austria GmbH
• 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