Prescription drug · NDA
Ponvory (Ponesimod) NDC 50458-720
Ponesimod 20 mg/1 · Tablet, Film coated · Oral · Janssen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-720-30 | 5045807203050458072030 | 1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 18, 2021 |
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
- Active ingredients
- Ponesimod — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Pharmaceuticals, IncNDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213498
- Marketing start
- Marketing end
- Other FDA classes
- Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
- Identifiers
- Product ID 50458-720_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
- Pharmacologic class
- Sphingosine 1-phosphate Receptor Modulator
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450458072030followed by a unit qualifier and the quantityPackage 50458-0720-30. 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 50458-720
- What is NDC 50458-720?
- 50458-720 is the product NDC for Ponvory (ponesimod), Ponesimod 20 mg/1 tablet, film coated, listed with the FDA by Janssen Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ponvory (Ponesimod).
- What is the active ingredient?
- 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 | — | Kit | Janssen Pharmaceuticals, Inc | 50458-707 | — |
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 | — | Kit | Janssen Pharmaceuticals, Inc | 50458-707 |