NDC 18124-011 Cleviprex

Clevidipine Emulsion Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
18124-011
Proprietary Name:
Cleviprex
Non-Proprietary Name: [1]
Clevidipine
Substance Name: [2]
Clevidipine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Fresenius Kabi Austria Gmbh
    Labeler Code:
    18124
    FDA Application Number: [6]
    NDA022156
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-15-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - MILKY)

    Product Packages

    NDC Code 18124-011-00

    Package Description: 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USE

    NDC Code 18124-011-25

    Package Description: 4 CARTON in 1 CARTON / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USE

    NDC Code 18124-011-50

    Package Description: 10 CARTON in 1 CARTON / 1 VIAL, SINGLE-USE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-USE

    Product Details

    What is NDC 18124-011?

    The NDC code 18124-011 is assigned by the FDA to the product Cleviprex which is a human prescription drug product labeled by Fresenius Kabi Austria Gmbh. The generic name of Cleviprex is clevidipine. The product's dosage form is emulsion and is administered via intravenous form. The product is distributed in 3 packages with assigned NDC codes 18124-011-00 10 carton in 1 carton / 1 vial, single-use in 1 carton / 100 ml in 1 vial, single-use, 18124-011-25 4 carton in 1 carton / 1 vial, single-use in 1 carton / 250 ml in 1 vial, single-use, 18124-011-50 10 carton in 1 carton / 1 vial, single-use in 1 carton / 50 ml in 1 vial, single-use. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Cleviprex?

    Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.

    What are Cleviprex Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Cleviprex UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Cleviprex Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Cleviprex?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Cleviprex?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".