Ponvory Tablet, Film Coated
NDC Package 43068-620-01

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

Package Information

Ponvory (ponesimod) tablets is pONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. This formulation utilizes a tablet, film coated delivery system. Marketed by Vanda Pharmaceuticals Inc., this product is identified by NDC 43068-620 and is authorized under FDA application NDA213498.

Identification & Billing

NDC Package Code
43068-620-01
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
43068-620
11-Digit Billing Format
43068062001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ponvory
Non-Proprietary Name
Ponesimod
Substance Name
Ponesimod
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PONESIMOD 20 mg/1
Pharmacologic Class
Usage Information
PONVORY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Regulatory & Marketing

Labeler Name
Vanda Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213498
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-18-2021
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 43068-620-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Ponvory, a human prescription drug labeled by Vanda Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains ponesimod 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 Vanda Pharmaceuticals Inc. on March 18, 2021. The current certification is valid through December 31, 2026.

How is this Vanda Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43068062001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
43068-620-01
11-Digit CMS (5-4-2)
43068-0620-01

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