Ponvory Kit
NDC Package 43068-610-09

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

Package Information

Ponvory (ponesimod) kits 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 kit delivery system. Marketed by Vanda Pharmaceuticals Inc., this product is identified by NDC 43068-610 and is authorized under FDA application NDA213498.

Identification & Billing

NDC Package Code
43068-610-09
Package Description
1 KIT in 1 CARTON * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
43068-610
11-Digit Billing Format
43068061009
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ponvory
Non-Proprietary Name
Ponesimod
Dosage Form
Kit - A packaged collection of related material.
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
  • 43068 - Vanda Pharmaceuticals Inc.
    • 43068-610 - Ponvory
      • 43068-610-09 - 1 KIT in 1 CARTON * 1 BLISTER PACK in 1 CARTON (43068-606-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-609-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-608-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-607-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-611-00) / 3 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-605-00) / 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-604-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-603-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (43068-602-00) / 2 TABLET, FILM COATED in 1 BLISTER PACK

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 43068-610-09 identifies a specific commercial package of 1 kit in 1 carton * 1 blister pack in 1 carton (43068-606-00) / 1 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-609-00) / 1 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-608-00) / 1 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-607-00) / 1 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-611-00) / 3 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-605-00) / 1 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-604-00) / 2 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-603-00) / 2 tablet, film coated in 1 blister pack * 1 blister pack in 1 carton (43068-602-00) / 2 tablet, film coated in 1 blister pack of Ponvory, a human prescription drug labeled by Vanda Pharmaceuticals Inc.. This kit is formulated for use and contains 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: 43068061009. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
43068-610-09
11-Digit CMS (5-4-2)
43068-0610-09

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