NDC codes

FDA NDC Directory
Product NDC (as listed)43068-620Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43068-0620Add 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 NDC11-digit (billing)PackageCopy
43068-620-01430680620011 BOTTLE in 1 CARTON (43068-620-01) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed 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
Active ingredients
Ponesimod — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213498
Marketing start
Listing expires
Other FDA classes
Sphingosine 1-Phosphate Receptor Modulators (Mechanism)
Identifiers
Product ID 43068-620_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
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

N443068062001 followed by a unit qualifier and the quantity

Package 43068-0620-01. 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.

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
ProductStrengthForm · routeLabelerProduct NDC
Ponvoryponesimod—KitVanda Pharmaceuticals Inc.43068-610
Ponvoryponesimod—KitJanssen Pharmaceuticals, Inc50458-707
PonvoryponesimodPonesimod 20 mg/1Tablet, Film coatedOralJanssen Pharmaceuticals, Inc50458-720

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