Home NDC 50458-707-14 PONVORY
Product NDC 50458-707
Requested package NDC 50458-707-14
11-digit product format 504580707
Labeler code 50458
Product ID 50458-707_339b28be-aa00-df1a-e063-6294a90a5453
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ponesimod
Dosage form KIT
Labeler Janssen Pharmaceuticals, Inc
Application NDA213498
Marketing category NDA
Marketing start 2021-03-18
Marketing end 2027-03-31
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 10 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213498-001 PONVORY PONESIMOD 2MG TABLET / ORAL RLD, RS 2021-03-18 N213498-002 PONVORY PONESIMOD 3MG TABLET / ORAL RLD 2021-03-18 N213498-003 PONVORY PONESIMOD 4MG TABLET / ORAL RLD 2021-03-18 N213498-004 PONVORY PONESIMOD 5MG TABLET / ORAL RLD 2021-03-18 N213498-005 PONVORY PONESIMOD 6MG TABLET / ORAL RLD 2021-03-18 N213498-006 PONVORY PONESIMOD 7MG TABLET / ORAL RLD 2021-03-18 N213498-007 PONVORY PONESIMOD 8MG TABLET / ORAL RLD 2021-03-18 N213498-008 PONVORY PONESIMOD 9MG TABLET / ORAL RLD 2021-03-18 N213498-009 PONVORY PONESIMOD 10MG TABLET / ORAL RLD 2021-03-18 N213498-010 PONVORY PONESIMOD 20MG TABLET / ORAL RLD 2021-03-18
Orange Book patents# Current patent rows page 1 of 1 · 50 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213498-001 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-001 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-001 10220023 2035-12-10 U-3103 2021-04-14 N213498-001 12336980 2035-12-10 U-3103 2025-07-08 N213498-001 11951097 2042-10-10 U-3891 2024-05-02 N213498-002 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-002 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-002 10220023 2035-12-10 U-3103 2021-04-14 N213498-002 12336980 2035-12-10 U-3103 2025-07-08 N213498-002 11951097 2042-10-10 U-3891 2024-05-02 N213498-003 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-003 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-003 10220023 2035-12-10 U-3103 2021-04-14 N213498-003 12336980 2035-12-10 U-3103 2025-07-08 N213498-003 11951097 2042-10-10 U-3891 2024-05-02 N213498-004 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-004 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-004 10220023 2035-12-10 U-3103 2021-04-14 N213498-004 12336980 2035-12-10 U-3103 2025-07-08 N213498-004 11951097 2042-10-10 U-3891 2024-05-02 N213498-005 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-005 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-005 10220023 2035-12-10 U-3103 2021-04-14 N213498-005 12336980 2035-12-10 U-3103 2025-07-08 N213498-005 11951097 2042-10-10 U-3891 2024-05-02 N213498-006 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-006 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-006 10220023 2035-12-10 U-3103 2021-04-14 N213498-006 12336980 2035-12-10 U-3103 2025-07-08 N213498-006 11951097 2042-10-10 U-3891 2024-05-02 N213498-007 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-007 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-007 10220023 2035-12-10 U-3103 2021-04-14 N213498-007 12336980 2035-12-10 U-3103 2025-07-08 N213498-007 11951097 2042-10-10 U-3891 2024-05-02 N213498-008 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-008 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-008 10220023 2035-12-10 U-3103 2021-04-14 N213498-008 12336980 2035-12-10 U-3103 2025-07-08 N213498-008 11951097 2042-10-10 U-3891 2024-05-02 N213498-009 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-009 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-009 10220023 2035-12-10 U-3103 2021-04-14 N213498-009 12336980 2035-12-10 U-3103 2025-07-08 N213498-009 11951097 2042-10-10 U-3891 2024-05-02 N213498-010 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 N213498-010 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 N213498-010 10220023 2035-12-10 U-3103 2021-04-14 N213498-010 12336980 2035-12-10 U-3103 2025-07-08 N213498-010 11951097 2042-10-10 U-3891 2024-05-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 10 matching rows.
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N213498-001 PONVORY 2MG TABLET / ORAL RLD, RS 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-002 PONVORY 3MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-003 PONVORY 4MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-004 PONVORY 5MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-005 PONVORY 6MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-006 PONVORY 7MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-007 PONVORY 8MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-008 PONVORY 9MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-009 PONVORY 10MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-010 PONVORY 20MG TABLET / ORAL RLD 2021-03-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 50 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N213498-001 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-001 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-001 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-001 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-001 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-002 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-002 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-002 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-002 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-002 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-003 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-003 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-003 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-003 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-003 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-004 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-004 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-004 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-004 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-004 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-005 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-005 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-005 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-005 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-005 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-006 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-006 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-006 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-006 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-006 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-007 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-007 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-007 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-007 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-007 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-008 RE43728 2029-11-16 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-008 9062014 2032-05-06 U-2774 Drug substance, Drug product 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-008 10220023 2035-12-10 U-3103 2021-04-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-008 12336980 2035-12-10 U-3103 2025-07-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N213498-008 11951097 2042-10-10 U-3891 2024-05-02 a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PONVORY Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5G7AKV2MKP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 2 · 22 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50458-702-00 PONVORY 2 in 1 BLISTER PACK TABLET, FILM COATED 2 2 mg 13 50458-702-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 2 mg 13 50458-703-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 3 mg 13 50458-703-00 PONVORY 2 in 1 BLISTER PACK TABLET, FILM COATED 2 3 mg 13 50458-704-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 4 mg 13 50458-704-00 PONVORY 2 in 1 BLISTER PACK TABLET, FILM COATED 2 4 mg 13 50458-705-00 PONVORY 1 in 1 BLISTER PACK TABLET, FILM COATED 1 5 mg 13 50458-705-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 5 mg 13 50458-706-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 6 mg 13 50458-706-00 PONVORY 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6 mg 13 50458-707-14 PONVORY 1 in 1 CARTON KIT 1 13 50458-708-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 8 mg 13 50458-708-00 PONVORY 1 in 1 BLISTER PACK TABLET, FILM COATED 1 8 mg 13 50458-709-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 9 mg 13 50458-709-00 PONVORY 1 in 1 BLISTER PACK TABLET, FILM COATED 1 9 mg 13 50458-710-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 10 mg 13 50458-710-00 PONVORY 3 in 1 BLISTER PACK TABLET, FILM COATED 3 10 mg 13 50458-711-00 PONVORY 1 in 1 CARTON TABLET, FILM COATED 7 mg 13 50458-711-00 PONVORY 1 in 1 BLISTER PACK TABLET, FILM COATED 1 7 mg 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50458-707 PONVORY (PONESIMOD) TABLET, FILM COATED PONVORY (PONESIMOD) KIT [JANSSEN PHARMACEUTICALS, INC] 13 Current NDC, Legacy NDC, 19 package rows 20250427_5be69660-738c-4db7-b0d4-517aa873dc41.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50458-707-14 50458070714 1 KIT in 1 CARTON (50458-707-14) * 1 BLISTER PACK in 1 CARTON (50458-706-00) > 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-709-00) > 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-708-00) > 1 TABLET, FILM COATED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (50458-711-00) > 1 TA 1 kit 2021-03-18 0000-00-00 No No Current