Prescription drug · NDA
Ponvory (Ponesimod) NDC 43068-610
Kit · Vanda Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43068-610-09 | 4306806100943068061009 | 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.NDC labeler code 43068
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213498
- Marketing start
- Listing expires
- 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
N443068061009followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 43068-610
- What is NDC 43068-610?
- 43068-610 is the product NDC for Ponvory (ponesimod) kit, listed with the FDA by Vanda Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ponvory (Ponesimod).
- Who is the labeler?
- Vanda Pharmaceuticals Inc., NDC labeler code 43068. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ponvory?
- 3 other product NDCs are listed under this name. See all Ponvory NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ponvory products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ponvoryponesimod | Ponesimod 20 mg/1 | Tablet, Film coatedOral | Vanda Pharmaceuticals Inc. | 43068-620 | 43068-0620-01 |
| Ponvoryponesimod | — | Kit | Janssen Pharmaceuticals, Inc | 50458-707 | — |
| Ponvoryponesimod | Ponesimod 20 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc | 50458-720 | 50458-0720-30 |
Other NDCs under NDA 213498
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |