FDA.reportPublic FDA data

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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5G7AKV2MKP
Rxcui2532305, 2532311, 2532314, 2532316, 2532318, 2532320, 2532322, 2532324, 2532327, 2532329, 2532331, 2532333, 2532335, 2532337, 2532339, 2532341, 2532343, 2532345, 2532347, 2532349

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

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 kit2024-11-01NoNoHistorical
43068-611-00430680611001 in 1 CARTONHistorical