NDC 10122-610

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 ID10122-610_02b98b53-8d6d-46e5-85f3-5ec9e7b6360d
NDC10122-610
Product TypeHuman Prescription Drug
Proprietary NameCleviprex
Generic NameClevipidine
Dosage FormEmulsion
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-09-15
Marketing CategoryNDA / NDA
Application NumberNDA022156
Labeler NameChiesi USA, Inc.
Substance NameCLEVIDIPINE
Active Ingredient Strength1 mg/mL
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10122-610-10

10 CARTON in 1 CARTON (10122-610-10) > 1 VIAL, SINGLE-USE in 1 CARTON (10122-610-01) > 50 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2008-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10122-610-01 [10122061001]

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

NDC 10122-610-10 [10122061010]

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

Drug Details

Active Ingredients

IngredientStrength
CLEVIDIPINE.5 mg/mL

OpenFDA Data

SPL SET ID:f9290625-b723-4eda-bab8-a97bef6041f6
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 "Clevipidine"

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.