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

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-product	Trade name	Ingredient	Strength	Dosage form / route	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213498-001	NCE	2026-03-18
N213498-002	NCE	2026-03-18
N213498-003	NCE	2026-03-18
N213498-004	NCE	2026-03-18
N213498-005	NCE	2026-03-18
N213498-006	NCE	2026-03-18
N213498-007	NCE	2026-03-18
N213498-008	NCE	2026-03-18
N213498-009	NCE	2026-03-18
N213498-010	NCE	2026-03-18

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`

Observed Orange Book patent history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213498-001	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213498-001	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-009	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-010	NCE	2026-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213498-001	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-002	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-003	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-004	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-005	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-006	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-007	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-008	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-009	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-010	NCE	2026-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213498-001	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-002	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-003	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-004	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-005	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-006	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-007	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-008	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-009	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-010	NCE	2026-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-001	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-002	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-003	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-004	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-005	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-006	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-007	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-008	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-009	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-010	NCE	2026-03-18	`31067a03dcf5…`

Additional Listing Data#

Finished product: Yes
Brand name base: PONVORY

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PONESIMOD	20 mg/1

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.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5be69660-738c-4db7-b0d4-517aa873dc41	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d2de6260-6c97-4404-afa7-929cb91a2ab5	Product name	1	20210916

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50458-720-30	PONVORY	30 in 1 BOTTLE	TABLET, FILM COATED	30		13
50458-720-30	PONVORY	1 in 1 CARTON	TABLET, FILM COATED	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-720-30	EA - Each	50458-720	088c1aa3-b182-407f-9bb0-7187404c9e2e	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-720	PONVORY (PONESIMOD) TABLET, FILM COATED PONVORY (PONESIMOD) KIT [JANSSEN PHARMACEUTICALS, INC]	13	Current NDC, Legacy NDC, 2 package rows	20250427_5be69660-738c-4db7-b0d4-517aa873dc41.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PONVORY	PONESIMOD	Vanda Pharmaceuticals Inc.	0c025ba8-ba51-272e-e063-6294a90ad120	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213498 application number: NDA213498
PONVORY	PONESIMOD	Janssen Pharmaceuticals, Inc	5be69660-738c-4db7-b0d4-517aa873dc41	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213498 application number: NDA213498 ndc (product): 50458-720

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5G7AKV2MKP	PONESIMOD	854107-55-4	PONESIMOD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL 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]	BPCK	5be69660-738c-4db7-b0d4-517aa873dc41	13
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) } Pack	GPCK	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532305	ponesimod 10 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532350	ponesimod 14 Day Pack	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532314	ponesimod 2 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532318	ponesimod 20 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532322	ponesimod 3 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532327	ponesimod 4 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532331	ponesimod 5 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532335	ponesimod 6 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532339	ponesimod 7 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532343	ponesimod 8 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532347	ponesimod 9 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532311	Ponvory 10 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532351	Ponvory 14 Day Pack	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532316	Ponvory 2 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532320	Ponvory 20 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532324	Ponvory 3 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532329	Ponvory 4 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532333	Ponvory 5 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532337	Ponvory 6 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532341	Ponvory 7 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532345	Ponvory 8 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532349	Ponvory 9 MG Oral Tablet	PSN	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532311	ponesimod 10 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532316	ponesimod 2 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532320	ponesimod 20 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532324	ponesimod 3 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532329	ponesimod 4 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532333	ponesimod 5 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532337	ponesimod 6 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532341	ponesimod 7 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532345	ponesimod 8 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532349	ponesimod 9 MG Oral Tablet [Ponvory]	SBD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532305	ponesimod 10 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532314	ponesimod 2 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532318	ponesimod 20 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532322	ponesimod 3 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532327	ponesimod 4 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532331	ponesimod 5 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532335	ponesimod 6 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532339	ponesimod 7 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532343	ponesimod 8 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532347	ponesimod 9 MG Oral Tablet	SCD	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532350	ponesimod 14 Day Pack	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532311	Ponvory 10 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532351	Ponvory 14 Day Pack	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532316	Ponvory 2 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532320	Ponvory 20 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532324	Ponvory 3 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532329	Ponvory 4 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532333	Ponvory 5 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532337	Ponvory 6 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532341	Ponvory 7 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532345	Ponvory 8 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13
2532349	Ponvory 9 MG Oral Tablet	SY	5be69660-738c-4db7-b0d4-517aa873dc41	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-720-30	50458072030	1 BOTTLE in 1 CARTON (50458-720-30) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-03-18	2027-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PONVORY	Janssen Pharmaceuticals, Inc \| Patheon Austria GmbH & Co KG \| ACM Pharma \| Jetpharma SA \| Konapharma AG \| Patheon France	2025-04-25	HUMAN PRESCRIPTION DRUG LABEL	13