Prescription drug · NDA
Ponvory (Ponesimod) NDC 50458-707
Kit · Janssen Pharmaceuticals, Inc
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Ponvory
- Generic name (nonproprietary)
- ponesimod
- Dosage form
- Kit
- Labeler
- Janssen Pharmaceuticals, IncNDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213498
- Marketing start
- Marketing end
- Identifiers
- Product ID 50458-707_339b28be-aa00-df1a-e063-6294a90a5453SPL ID 339b28be-aa00-df1a-e063-6294a90a5453SPL set ID 5be69660-738c-4db7-b0d4-517aa873dc41RxCUI 2532305, 2532311, 2532314, 2532316, 2532318, 2532320, 2532322, 2532324, 2532327, 2532329, 2532331, 2532333, 2532335, 2532337, 2532339, 2532341, 2532343, 2532345, 2532347, 2532349, 2532350, 2532351UNII 5G7AKV2MKP
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.
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 50458-707
- What is NDC 50458-707?
- 50458-707 is the product NDC for Ponvory (ponesimod) kit, listed with the FDA by Janssen Pharmaceuticals, Inc.
- What drug is associated with this NDC?
- Ponvory (Ponesimod).
- Who is the labeler?
- Janssen Pharmaceuticals, Inc, NDC labeler code 50458. 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 | — | Kit | Vanda Pharmaceuticals Inc. | 43068-610 | 43068-0610-09 |
| Ponvoryponesimod | Ponesimod 20 mg/1 | Tablet, Film coatedOral | Vanda Pharmaceuticals Inc. | 43068-620 | 43068-0620-01 |
| 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 | — | Kit | Vanda Pharmaceuticals Inc. | 43068-610 |
| Ponvoryponesimod | Ponesimod 20 mg/1 | Tablet, Film coatedOral | Vanda Pharmaceuticals Inc. | 43068-620 |
| Ponvoryponesimod | Ponesimod 20 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc | 50458-720 |