Cleviprex Emulsion
NDC Package 10122-610-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cleviprex (clevipidine) emulsions is cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. This formulation utilizes a emulsion delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-610 and is authorized under FDA application NDA022156.

Identification & Billing

NDC Package Code
10122-610-10
Package Description
10 CARTON in 1 CARTON / 1 VIAL, SINGLE-USE in 1 CARTON (10122-610-01) / 50 mL in 1 VIAL, SINGLE-USE
Product Code
10122-610
11-Digit Billing Format
10122061010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cleviprex
Non-Proprietary Name
Clevipidine
Substance Name
Clevidipine
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CLEVIDIPINE .5 mg/mL
Pharmacologic Class
Usage Information
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Regulatory & Marketing

Labeler Name
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022156
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-15-2008
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10122-610-10 identifies a specific commercial package of 10 carton in 1 carton / 1 vial, single-use in 1 carton (10122-610-01) / 50 ml in 1 vial, single-use of Cleviprex, a human prescription drug labeled by Chiesi Usa, Inc.. This emulsion is formulated for intravenous use and contains clevidipine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Chiesi Usa, Inc. on September 15, 2008. The current certification is valid through December 31, 2026.

How is this Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122061010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10122-610-10
11-Digit CMS (5-4-2)
10122-0610-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.