PONVORY

Product NDC
43068-610
11-digit product format
430680610
Labeler code
43068
Product ID
43068-610_5280b437-62d4-417f-bd65-eb8944a85166
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ponesimod
Dosage form
KIT
Labeler
Vanda Pharmaceuticals Inc.
Application
NDA213498
Marketing category
NDA
Marketing start
2021-03-18
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N213498-001PONVORYPONESIMOD2MGTABLET / ORALRLD, RS2021-03-18
N213498-002PONVORYPONESIMOD3MGTABLET / ORALRLD2021-03-18
N213498-003PONVORYPONESIMOD4MGTABLET / ORALRLD2021-03-18
N213498-004PONVORYPONESIMOD5MGTABLET / ORALRLD2021-03-18
N213498-005PONVORYPONESIMOD6MGTABLET / ORALRLD2021-03-18
N213498-006PONVORYPONESIMOD7MGTABLET / ORALRLD2021-03-18
N213498-007PONVORYPONESIMOD8MGTABLET / ORALRLD2021-03-18
N213498-008PONVORYPONESIMOD9MGTABLET / ORALRLD2021-03-18
N213498-009PONVORYPONESIMOD10MGTABLET / ORALRLD2021-03-18
N213498-010PONVORYPONESIMOD20MGTABLET / ORALRLD2021-03-18

Orange Book patents#

Current patent rows page 1 of 1 · 50 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N213498-001RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00190620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-001102200232035-12-10U-31032021-04-14
N213498-001123369802035-12-10U-31032025-07-08
N213498-001119510972042-10-10U-38912024-05-02
N213498-002RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00290620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-002102200232035-12-10U-31032021-04-14
N213498-002123369802035-12-10U-31032025-07-08
N213498-002119510972042-10-10U-38912024-05-02
N213498-003RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00390620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-003102200232035-12-10U-31032021-04-14
N213498-003123369802035-12-10U-31032025-07-08
N213498-003119510972042-10-10U-38912024-05-02
N213498-004RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00490620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-004102200232035-12-10U-31032021-04-14
N213498-004123369802035-12-10U-31032025-07-08
N213498-004119510972042-10-10U-38912024-05-02
N213498-005RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00590620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-005102200232035-12-10U-31032021-04-14
N213498-005123369802035-12-10U-31032025-07-08
N213498-005119510972042-10-10U-38912024-05-02
N213498-006RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00690620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-006102200232035-12-10U-31032021-04-14
N213498-006123369802035-12-10U-31032025-07-08
N213498-006119510972042-10-10U-38912024-05-02
N213498-007RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00790620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-007102200232035-12-10U-31032021-04-14
N213498-007123369802035-12-10U-31032025-07-08
N213498-007119510972042-10-10U-38912024-05-02
N213498-008RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00890620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-008102200232035-12-10U-31032021-04-14
N213498-008123369802035-12-10U-31032025-07-08
N213498-008119510972042-10-10U-38912024-05-02
N213498-009RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-00990620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-009102200232035-12-10U-31032021-04-14
N213498-009123369802035-12-10U-31032025-07-08
N213498-009119510972042-10-10U-38912024-05-02
N213498-010RE437282029-11-16Drug substance, Drug product2021-04-14
N213498-01090620142032-05-06U-2774Drug substance, Drug product2021-04-14
N213498-010102200232035-12-10U-31032021-04-14
N213498-010123369802035-12-10U-31032025-07-08
N213498-010119510972042-10-10U-38912024-05-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N213498-001NCE2026-03-18
N213498-002NCE2026-03-18
N213498-003NCE2026-03-18
N213498-004NCE2026-03-18
N213498-005NCE2026-03-18
N213498-006NCE2026-03-18
N213498-007NCE2026-03-18
N213498-008NCE2026-03-18
N213498-009NCE2026-03-18
N213498-010NCE2026-03-18

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N213498-001PONVORY2MGTABLET / ORALRLD, RS2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-002PONVORY3MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-003PONVORY4MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-004PONVORY5MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-005PONVORY6MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-006PONVORY7MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-007PONVORY8MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-008PONVORY9MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-009PONVORY10MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-010PONVORY20MGTABLET / ORALRLD2021-03-1884e616aacf4f…
2026-08-18 06:07:402026-07N213498-001PONVORY2MGTABLET / ORALRLD, RS2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-002PONVORY3MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-003PONVORY4MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-004PONVORY5MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-005PONVORY6MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-006PONVORY7MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-007PONVORY8MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-008PONVORY9MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-009PONVORY10MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-010PONVORY20MGTABLET / ORALRLD2021-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213498-001PONVORY2MGTABLET / ORALRLD, RS2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-002PONVORY3MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-003PONVORY4MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-004PONVORY5MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-005PONVORY6MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-006PONVORY7MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-007PONVORY8MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-008PONVORY9MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-009PONVORY10MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-010PONVORY20MGTABLET / ORALRLD2021-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-001PONVORY2MGTABLET / ORALRLD, RS2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-002PONVORY3MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-003PONVORY4MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-004PONVORY5MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-005PONVORY6MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-006PONVORY7MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-007PONVORY8MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-008PONVORY9MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-009PONVORY10MGTABLET / ORALRLD2021-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-010PONVORY20MGTABLET / ORALRLD2021-03-1831067a03dcf5…

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,860 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N213498-001RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00190620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-001102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-001123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-001119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-002RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00290620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-002102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-002123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-002119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-003RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00390620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-003102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-003123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-003119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-004RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00490620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-004102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-004123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-004119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-005RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00590620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-005102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-005123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-005119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-006RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00690620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-006102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-006123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-006119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-007RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00790620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-007102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-007123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-007119510972042-10-10U-38912024-05-0284e616aacf4f…
2026-09-14 22:38:342026-08N213498-008RE437282029-11-16Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-00890620142032-05-06U-2774Drug substance, Drug product2021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-008102200232035-12-10U-31032021-04-1484e616aacf4f…
2026-09-14 22:38:342026-08N213498-008123369802035-12-10U-31032025-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N213498-008119510972042-10-10U-38912024-05-0284e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N213498-001NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-002NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-003NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-004NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-005NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-006NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-007NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-008NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-009NCE2026-03-1884e616aacf4f…
2026-09-14 22:38:342026-08N213498-010NCE2026-03-1884e616aacf4f…
2026-08-18 06:07:402026-07N213498-001NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-002NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-003NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-004NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-005NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-006NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-007NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-008NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-009NCE2026-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07N213498-010NCE2026-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N213498-001NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-002NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-003NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-004NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-005NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-006NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-007NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-008NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-009NCE2026-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N213498-010NCE2026-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-001NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-002NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-003NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-004NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-005NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-006NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-007NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-008NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-009NCE2026-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N213498-010NCE2026-03-1831067a03dcf5…

Additional Listing Data#

Finished product
Yes
Brand name base
PONVORY
Listing expiration
2026-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5G7AKV2MKPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2532305Internal RxNorm lookup
2532311Internal RxNorm lookup
2532314Internal RxNorm lookup
2532316Internal RxNorm lookup
2532318Internal RxNorm lookup
2532320Internal RxNorm lookup
2532322Internal RxNorm lookup
2532324Internal RxNorm lookup
2532327Internal RxNorm lookup
2532329Internal RxNorm lookup
2532331Internal RxNorm lookup
2532333Internal RxNorm lookup
2532335Internal RxNorm lookup
2532337Internal RxNorm lookup
2532339Internal RxNorm lookup
2532341Internal RxNorm lookup
2532343Internal RxNorm lookup
2532345Internal RxNorm lookup
2532347Internal RxNorm lookup
2532349Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c025ba8-ba51-272e-e063-6294a90ad120Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d2de6260-6c97-4404-afa7-929cb91a2ab5Product name120210916

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43068-602-00PONVORY1 in 1 CARTONTABLET, FILM COATED2 mg4
43068-602-00PONVORY2 in 1 BLISTER PACKTABLET, FILM COATED22 mg4
43068-603-00PONVORY2 in 1 BLISTER PACKTABLET, FILM COATED23 mg4
43068-603-00PONVORY1 in 1 CARTONTABLET, FILM COATED3 mg4
43068-604-00PONVORY2 in 1 BLISTER PACKTABLET, FILM COATED24 mg4
43068-604-00PONVORY1 in 1 CARTONTABLET, FILM COATED4 mg4
43068-605-00PONVORY1 in 1 CARTONTABLET, FILM COATED5 mg4
43068-605-00PONVORY1 in 1 BLISTER PACKTABLET, FILM COATED15 mg4
43068-606-00PONVORY1 in 1 BLISTER PACKTABLET, FILM COATED16 mg4
43068-606-00PONVORY1 in 1 CARTONTABLET, FILM COATED6 mg4
43068-607-00PONVORY1 in 1 CARTONTABLET, FILM COATED7 mg4
43068-607-00PONVORY1 in 1 BLISTER PACKTABLET, FILM COATED17 mg4
43068-608-00PONVORY1 in 1 BLISTER PACKTABLET, FILM COATED18 mg4
43068-608-00PONVORY1 in 1 CARTONTABLET, FILM COATED8 mg4
43068-609-00PONVORY1 in 1 BLISTER PACKTABLET, FILM COATED19 mg4
43068-609-00PONVORY1 in 1 CARTONTABLET, FILM COATED9 mg4
43068-610-09PONVORY1 in 1 CARTONKIT14
43068-611-00PONVORY1 in 1 CARTONTABLET, FILM COATED10 mg4
43068-611-00PONVORY3 in 1 BLISTER PACKTABLET, FILM COATED310 mg4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43068-610-09EA - Each43068-610d3fbddda-c609-49a3-93f8-cc3fe6fe584612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43068-610PONVORY (PONESIMOD) TABLET, FILM COATED PONVORY (PONESIMOD) KIT [VANDA PHARMACEUTICALS INC.]3Current NDC, 19 package rows20241103_0c025ba8-ba51-272e-e063-6294a90ad120.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PONVORYPONESIMODVanda Pharmaceuticals Inc.0c025ba8-ba51-272e-e063-6294a90ad1202025-12-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 213498
application number: NDA213498
ndc (product): 43068-610
PONVORYPONESIMODJanssen Pharmaceuticals, Inc5be69660-738c-4db7-b0d4-517aa873dc412025-04-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 213498
application number: NDA213498

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2532351{3 (ponesimod 10 MG Oral Tablet [Ponvory]) / 2 (ponesimod 2 MG Oral Tablet [Ponvory]) / 2 (ponesimod 3 MG Oral Tablet [Ponvory]) / 2 (ponesimod 4 MG Oral Tablet [Ponvory]) / 1 (ponesimod 5 MG Oral Tablet [Ponvory]) / 1 (ponesimod 6 MG Oral Tablet [Ponvory]) / 1 (ponesimod 7 MG Oral Tablet [Ponvory]) / 1 (ponesimod 8 MG Oral Tablet [Ponvory]) / 1 (ponesimod 9 MG Oral Tablet [Ponvory]) } Pack [Ponvory 14 Day]BPCK0c025ba8-ba51-272e-e063-6294a90ad1204
2532350{3 (ponesimod 10 MG Oral Tablet) / 2 (ponesimod 2 MG Oral Tablet) / 2 (ponesimod 3 MG Oral Tablet) / 2 (ponesimod 4 MG Oral Tablet) / 1 (ponesimod 5 MG Oral Tablet) / 1 (ponesimod 6 MG Oral Tablet) / 1 (ponesimod 7 MG Oral Tablet) / 1 (ponesimod 8 MG Oral Tablet) / 1 (ponesimod 9 MG Oral Tablet) } PackGPCK0c025ba8-ba51-272e-e063-6294a90ad1204
2532305ponesimod 10 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532350ponesimod 14 Day PackPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532314ponesimod 2 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532318ponesimod 20 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532322ponesimod 3 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532327ponesimod 4 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532331ponesimod 5 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532335ponesimod 6 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532339ponesimod 7 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532343ponesimod 8 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532347ponesimod 9 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532311Ponvory 10 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532351Ponvory 14 Day PackPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532316Ponvory 2 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532320Ponvory 20 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532324Ponvory 3 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532329Ponvory 4 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532333Ponvory 5 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532337Ponvory 6 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532341Ponvory 7 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532345Ponvory 8 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532349Ponvory 9 MG Oral TabletPSN0c025ba8-ba51-272e-e063-6294a90ad1204
2532311ponesimod 10 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532316ponesimod 2 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532320ponesimod 20 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532324ponesimod 3 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532329ponesimod 4 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532333ponesimod 5 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532337ponesimod 6 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532341ponesimod 7 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532345ponesimod 8 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532349ponesimod 9 MG Oral Tablet [Ponvory]SBD0c025ba8-ba51-272e-e063-6294a90ad1204
2532305ponesimod 10 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532314ponesimod 2 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532318ponesimod 20 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532322ponesimod 3 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532327ponesimod 4 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532331ponesimod 5 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532335ponesimod 6 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532339ponesimod 7 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532343ponesimod 8 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532347ponesimod 9 MG Oral TabletSCD0c025ba8-ba51-272e-e063-6294a90ad1204
2532350ponesimod 14 Day PackSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532311Ponvory 10 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532351Ponvory 14 Day PackSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532316Ponvory 2 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532320Ponvory 20 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532324Ponvory 3 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532329Ponvory 4 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532333Ponvory 5 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532337Ponvory 6 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532341Ponvory 7 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532345Ponvory 8 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204
2532349Ponvory 9 MG Oral TabletSY0c025ba8-ba51-272e-e063-6294a90ad1204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43068-602-00430680602001 in 1 CARTONHistorical
43068-603-00430680603002 in 1 BLISTER PACKHistorical
43068-604-00430680604002 in 1 BLISTER PACKHistorical
43068-605-00430680605001 in 1 CARTONHistorical
43068-606-00430680606001 in 1 BLISTER PACKHistorical
43068-607-00430680607001 in 1 CARTONHistorical
43068-608-00430680608001 in 1 BLISTER PACKHistorical
43068-609-00430680609001 in 1 BLISTER PACKHistorical
43068-610-09430680610091 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 PACK1 kit2024-11-01NoNoCurrent
43068-611-00430680611001 in 1 CARTONHistorical