Ponvory (ponesimod) NDC 43068-610

NDC codes

FDA NDC Directory

Product NDC (as listed)43068-610Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43068-0610Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
43068-610-09	43068061009	1 KIT in 1 CARTON (43068-610-09) * 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 PACKMarketed from Nov 1, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Ponvory
Generic name (nonproprietary): ponesimod
Dosage form: Kit
Labeler: Vanda Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213498
Marketing start: Mar 18, 2021
Listing expires: Dec 31, 2026
Identifiers: Product ID 43068-610_5280b437-62d4-417f-bd65-eb8944a85166SPL ID 5280b437-62d4-417f-bd65-eb8944a85166SPL set ID 0c025ba8-ba51-272e-e063-6294a90ad120RxCUI 2532305, 2532311, 2532314, 2532316, 2532318, 2532320, 2532322, 2532324, 2532327, 2532329, 2532331, 2532333, 2532335, 2532337, 2532339, 2532341, 2532343, 2532345, 2532347, 2532349, 2532350, 2532351UNII 5G7AKV2MKPUPC 0343068620019

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N443068061009 followed by a unit qualifier and the quantity

Package 43068-0610-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 4, 2025.

Indications (excerpt from the label)

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. PONVORY is a sphingosine 1-phosphate receptor modulator 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 213498

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 213498
Product	Strength	Form · route	Labeler	Product NDC
Ponvoryponesimod	Ponesimod 20 mg/1	Tablet, Film coatedOral	Vanda Pharmaceuticals Inc.	43068-620
Ponvoryponesimod	—	Kit	Janssen Pharmaceuticals, Inc	50458-707
Ponvoryponesimod	Ponesimod 20 mg/1	Tablet, Film coatedOral	Janssen Pharmaceuticals, Inc	50458-720