NDC 65293-005-11 Cleviprex

Clevidipine

NDC Package Code 65293-005-11

Field Name Field Value
NDC Code 65293-005-11
Package Description 10 CARTON in 1 CARTON > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-00) > 100 mL in 1 VIAL, SINGLE-USE
Proprietary Name Cleviprex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Clevidipine 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.
11-Digit NDC Billing Format 65293000511 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Human Prescription Drug 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.
Labeler Name The Medicines Company
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)
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
  • CLEVIDIPINE .5 mg/mL
Pharmacological Class(es)
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Dihydropyridines - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA022156 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.
Start Marketing Date 09-15-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2017 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.

The NDC Code 65293-005-11 is assigned to Cleviprex, a human prescription drug labeled by The Medicines Company. The product's dosage form is emulsion and is administered via intravenous form.


Code Structure
  • 65293 - The Medicines Company
    • 65293-005 - Cleviprex
      • 65293-005-11 - 10 CARTON in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 65293-005-11 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
65293000511C9248Inj, clevidipine butyrate1 MG1001050500

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Other Product Packages

The following packages are also available for Cleviprex with product NDC 65293-005.

NDC Package CodePackage Description
65293-005-044 CARTON in 1 CARTON > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-25) > 250 mL in 1 VIAL, SINGLE-USE
65293-005-5510 CARTON in 1 CARTON > 1 VIAL, SINGLE-USE in 1 CARTON (65293-005-50) > 50 mL in 1 VIAL, SINGLE-USE

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