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 ID65293-005_c8c2dc00-90a3-11e4-b4a9-0800200c9a66
NDC65293-005
Product TypeHuman Prescription Drug
Proprietary NameCleviprex
Generic NameClevidipine
Dosage FormEmulsion
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-09-15
Marketing CategoryNDA / NDA
Application NumberNDA022156
Labeler NameThe Medicines Company
Substance NameCLEVIDIPINE
Active Ingredient Strength1 mg/mL
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

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 Date2008-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65293-005-55 [65293000555]

Cleviprex EMULSION
Marketing CategoryNDA
Application NumberNDA022156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-09-15
Marketing End Date2018-08-31

NDC 65293-005-25 [65293000525]

Cleviprex EMULSION
Marketing CategoryNDA
Application NumberNDA022156
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-12-31
Marketing End Date2018-08-31

NDC 65293-005-11 [65293000511]

Cleviprex EMULSION
Marketing CategoryNDA
Application NumberNDA022156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-09-15
Marketing End Date2018-08-31

NDC 65293-005-00 [65293000500]

Cleviprex EMULSION
Marketing CategoryNDA
Application NumberNDA022156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-09-15
Marketing End Date2018-08-31

NDC 65293-005-50 [65293000550]

Cleviprex EMULSION
Marketing CategoryNDA
Application NumberNDA022156
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-09-15
Marketing End Date2018-08-31

NDC 65293-005-04 [65293000504]

Cleviprex EMULSION
Marketing CategoryNDA
Application NumberNDA022156
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-09-15
Marketing End Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
CLEVIDIPINE.5 mg/mL

OpenFDA Data

SPL SET ID:095081a0-1398-11dc-82e1-0002a5d5c51b
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    10122-610Cleviprexclevipidine
    10122-611Cleviprexclevipidine
    10122-612Cleviprexclevipidine
    18124-011Cleviprexclevidipine
    65293-005Cleviprexclevidipine

    Trademark Results [Cleviprex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLEVIPREX
    CLEVIPREX
    90349617 not registered Live/Pending
    CHIESI FARMACEUTICI S.P.A.
    2020-11-30
    CLEVIPREX
    CLEVIPREX
    87442641 not registered Live/Pending
    Chiesi Farmaceutici S.P.A.
    2017-05-09
    CLEVIPREX
    CLEVIPREX
    77032009 3540746 Live/Registered
    CHIESI FARMACEUTICI S.P.A.
    2006-10-30

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