FDA.reportPublic FDA data

PONVORY

Product NDC
50458-720
11-digit product format
504580720
Labeler code
50458
Product ID
50458-720_339b28be-aa00-df1a-e063-6294a90a5453
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ponesimod
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Janssen Pharmaceuticals, Inc
Application
NDA213498
Marketing category
NDA
Marketing start
2021-03-18
Marketing end
2027-03-31
Substance
PONESIMOD
Active strength
20 mg/1
Pharmacologic classes
Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PONVORY

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PONESIMOD20 mg/1

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
50458-720-30PONVORY30 in 1 BOTTLETABLET, FILM COATED3013
50458-720-30PONVORY1 in 1 CARTONTABLET, FILM COATED113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-720-30EA - Each50458-720088c1aa3-b182-407f-9bb0-7187404c9e2e12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-720PONVORY (PONESIMOD) TABLET, FILM COATED PONVORY (PONESIMOD) KIT [JANSSEN PHARMACEUTICALS, INC]13Current NDC, Legacy NDC, 2 package rows20250427_5be69660-738c-4db7-b0d4-517aa873dc41.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]BPCK5be69660-738c-4db7-b0d4-517aa873dc4113
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) } PackGPCK5be69660-738c-4db7-b0d4-517aa873dc4113
2532305ponesimod 10 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532350ponesimod 14 Day PackPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532314ponesimod 2 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532318ponesimod 20 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532322ponesimod 3 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532327ponesimod 4 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532331ponesimod 5 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532335ponesimod 6 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532339ponesimod 7 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532343ponesimod 8 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532347ponesimod 9 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532311Ponvory 10 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532351Ponvory 14 Day PackPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532316Ponvory 2 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532320Ponvory 20 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532324Ponvory 3 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532329Ponvory 4 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532333Ponvory 5 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532337Ponvory 6 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532341Ponvory 7 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532345Ponvory 8 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532349Ponvory 9 MG Oral TabletPSN5be69660-738c-4db7-b0d4-517aa873dc4113
2532311ponesimod 10 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532316ponesimod 2 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532320ponesimod 20 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532324ponesimod 3 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532329ponesimod 4 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532333ponesimod 5 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532337ponesimod 6 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532341ponesimod 7 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532345ponesimod 8 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532349ponesimod 9 MG Oral Tablet [Ponvory]SBD5be69660-738c-4db7-b0d4-517aa873dc4113
2532305ponesimod 10 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532314ponesimod 2 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532318ponesimod 20 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532322ponesimod 3 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532327ponesimod 4 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532331ponesimod 5 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532335ponesimod 6 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532339ponesimod 7 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532343ponesimod 8 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532347ponesimod 9 MG Oral TabletSCD5be69660-738c-4db7-b0d4-517aa873dc4113
2532350ponesimod 14 Day PackSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532311Ponvory 10 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532351Ponvory 14 Day PackSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532316Ponvory 2 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532320Ponvory 20 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532324Ponvory 3 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532329Ponvory 4 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532333Ponvory 5 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532337Ponvory 6 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532341Ponvory 7 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532345Ponvory 8 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113
2532349Ponvory 9 MG Oral TabletSY5be69660-738c-4db7-b0d4-517aa873dc4113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50458-720-30504580720301 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-03-182027-03-31NoNoCurrent