SOHONOS

Product NDC: 15054-0010
11-digit product format: 150540010
Labeler code: 15054
Product ID: 15054-0010_cf7687df-422d-4e5d-a576-c11767f3f485
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: palovarotene
Dosage form: CAPSULE
Route: ORAL
Labeler: Ipsen Biopharmaceuticals, Inc.
Application: NDA215559
Marketing category: NDA
Marketing start: 2023-08-16
Substance: PALOVAROTENE
Active strength: 1 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215559-001	SOHONOS	PALOVAROTENE	1MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-002	SOHONOS	PALOVAROTENE	1.5MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-003	SOHONOS	PALOVAROTENE	2.5MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-004	SOHONOS	PALOVAROTENE	5MG	CAPSULE / ORAL	RLD	2023-08-16
N215559-005	SOHONOS	PALOVAROTENE	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16

Orange Book patents#

Current patent rows page 1 of 1 · 45 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N215559-001	10292954	2031-08-31	U-3676	2023-09-07
N215559-001	12023312	2031-08-31	U-3966	2024-07-25
N215559-001	9314439	2031-08-31	U-3676	2023-09-07
N215559-001	9789074	2031-08-31	U-3676	2023-09-07
N215559-001	11622959	2037-06-08	U-3676	2023-09-07
N215559-001	12138245	2037-06-08	U-4031	2024-11-15
N215559-001	12201614	2037-06-08	U-4031	2025-02-07
N215559-001	12458626	2037-06-08	U-3676	2025-12-03
N215559-001	10864194	2037-08-16	U-3676	2023-09-07
N215559-002	10292954	2031-08-31	U-3676	2023-09-07
N215559-002	12023312	2031-08-31	U-3966	2024-07-25
N215559-002	9314439	2031-08-31	U-3676	2023-09-07
N215559-002	9789074	2031-08-31	U-3676	2023-09-07
N215559-002	11622959	2037-06-08	U-3676	2023-09-07
N215559-002	12138245	2037-06-08	U-4031	2024-11-15
N215559-002	12201614	2037-06-08	U-4031	2025-02-07
N215559-002	12458626	2037-06-08	U-3676	2025-12-03
N215559-002	10864194	2037-08-16	U-3676	2023-09-07
N215559-003	10292954	2031-08-31	U-3676	2023-09-07
N215559-003	12023312	2031-08-31	U-3966	2024-07-25
N215559-003	9314439	2031-08-31	U-3676	2023-09-07
N215559-003	9789074	2031-08-31	U-3676	2023-09-07
N215559-003	11622959	2037-06-08	U-3676	2023-09-07
N215559-003	12138245	2037-06-08	U-4031	2024-11-15
N215559-003	12201614	2037-06-08	U-4031	2025-02-07
N215559-003	12458626	2037-06-08	U-3676	2025-12-03
N215559-003	10864194	2037-08-16	U-3676	2023-09-07
N215559-004	10292954	2031-08-31	U-3676	2023-09-07
N215559-004	12023312	2031-08-31	U-3966	2024-07-25
N215559-004	9314439	2031-08-31	U-3676	2023-09-07
N215559-004	9789074	2031-08-31	U-3676	2023-09-07
N215559-004	11622959	2037-06-08	U-3676	2023-09-07
N215559-004	12138245	2037-06-08	U-4031	2024-11-15
N215559-004	12201614	2037-06-08	U-4031	2025-02-07
N215559-004	12458626	2037-06-08	U-3676	2025-12-03
N215559-004	10864194	2037-08-16	U-3676	2023-09-07
N215559-005	10292954	2031-08-31	U-3676	2023-09-07
N215559-005	12023312	2031-08-31	U-3966	2024-07-25
N215559-005	9314439	2031-08-31	U-3676	2023-09-07
N215559-005	9789074	2031-08-31	U-3676	2023-09-07
N215559-005	11622959	2037-06-08	U-3676	2023-09-07
N215559-005	12138245	2037-06-08	U-4031	2024-11-15
N215559-005	12201614	2037-06-08	U-4031	2025-02-07
N215559-005	12458626	2037-06-08	U-3676	2025-12-03
N215559-005	10864194	2037-08-16	U-3676	2023-09-07

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215559-001	NCE	2028-08-16
N215559-001	ODE-439	2030-08-16
N215559-002	NCE	2028-08-16
N215559-002	ODE-439	2030-08-16
N215559-003	NCE	2028-08-16
N215559-003	ODE-439	2030-08-16
N215559-004	NCE	2028-08-16
N215559-004	ODE-439	2030-08-16
N215559-005	NCE	2028-08-16
N215559-005	ODE-439	2030-08-16

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 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 775 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215559-001	10292954	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	12023312	2031-08-31	U-3966	2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	9314439	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	9789074	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	11622959	2037-06-08	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	12138245	2037-06-08	U-4031	2024-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	12201614	2037-06-08	U-4031	2025-02-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	12458626	2037-06-08	U-3676	2025-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-001	10864194	2037-08-16	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	10292954	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	12023312	2031-08-31	U-3966	2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	9314439	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	9789074	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	11622959	2037-06-08	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	12138245	2037-06-08	U-4031	2024-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	12201614	2037-06-08	U-4031	2025-02-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	12458626	2037-06-08	U-3676	2025-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-002	10864194	2037-08-16	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	10292954	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	12023312	2031-08-31	U-3966	2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	9314439	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	9789074	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	11622959	2037-06-08	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	12138245	2037-06-08	U-4031	2024-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	12201614	2037-06-08	U-4031	2025-02-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	12458626	2037-06-08	U-3676	2025-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-003	10864194	2037-08-16	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	10292954	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	12023312	2031-08-31	U-3966	2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	9314439	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	9789074	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	11622959	2037-06-08	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	12138245	2037-06-08	U-4031	2024-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	12201614	2037-06-08	U-4031	2025-02-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	12458626	2037-06-08	U-3676	2025-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-004	10864194	2037-08-16	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-005	10292954	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-005	12023312	2031-08-31	U-3966	2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-005	9314439	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215559-005	9789074	2031-08-31	U-3676	2023-09-07	`c2088c7a36db…`

Observed Orange Book exclusivity history#

Exclusivity history page 3 of 6 · 230 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-001	NCE	2028-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-001	ODE-439	2030-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-002	NCE	2028-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-002	ODE-439	2030-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-003	NCE	2028-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-003	ODE-439	2030-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-004	NCE	2028-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-004	ODE-439	2030-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-005	NCE	2028-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-005	ODE-439	2030-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-001	NCE	2028-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-001	ODE-439	2030-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-002	NCE	2028-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-002	ODE-439	2030-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-003	NCE	2028-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-003	ODE-439	2030-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-004	NCE	2028-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-004	ODE-439	2030-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-005	NCE	2028-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-005	ODE-439	2030-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-001	NCE	2028-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-001	ODE-439	2030-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-002	NCE	2028-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-002	ODE-439	2030-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-003	NCE	2028-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-003	ODE-439	2030-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-004	NCE	2028-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-004	ODE-439	2030-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-005	NCE	2028-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-005	ODE-439	2030-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-001	NCE	2028-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-001	ODE-439	2030-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-002	NCE	2028-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-002	ODE-439	2030-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-003	NCE	2028-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-003	ODE-439	2030-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-004	NCE	2028-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-004	ODE-439	2030-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-005	NCE	2028-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215559-005	ODE-439	2030-08-16	`d8e5a09893c0…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: SOHONOS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALOVAROTENE	1 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
651c717d-4d6d-4238-a52b-c3ef32bb7888	Product name	1	20231024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15054-0010-1	SOHONOS	1 in 1 CARTON	CAPSULE	1		2
15054-0010-1	SOHONOS	14 in 1 BLISTER PACK	CAPSULE	14		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15054-0010-1	EA - Each	15054-0010	16fb2d70-322b-4a3b-970d-c057ca01ffaf	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15054-0010	SOHONOS (PALOVAROTENE) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20250323_67dce406-7cc4-4d66-92de-ad18b6df0625.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
28K6I5M16G	PALOVAROTENE	410528-02-8	PALOVAROTENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2663960	palovarotene 1 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663968	palovarotene 1.5 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663972	palovarotene 10 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663976	palovarotene 2.5 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663980	palovarotene 5 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663966	sohonos 1 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663970	sohonos 1.5 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663974	sohonos 10 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663978	sohonos 2.5 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663982	sohonos 5 MG Oral Capsule	PSN	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663966	palovarotene 1 MG Oral Capsule [Sohonos]	SBD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663970	palovarotene 1.5 MG Oral Capsule [Sohonos]	SBD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663974	palovarotene 10 MG Oral Capsule [Sohonos]	SBD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663978	palovarotene 2.5 MG Oral Capsule [Sohonos]	SBD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663982	palovarotene 5 MG Oral Capsule [Sohonos]	SBD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663960	palovarotene 1 MG Oral Capsule	SCD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663968	palovarotene 1.5 MG Oral Capsule	SCD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663972	palovarotene 10 MG Oral Capsule	SCD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663976	palovarotene 2.5 MG Oral Capsule	SCD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663980	palovarotene 5 MG Oral Capsule	SCD	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663960	palovarotene 1 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663968	palovarotene 1.5 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663972	palovarotene 10 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663976	palovarotene 2.5 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663980	palovarotene 5 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663966	Sohonos 1 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663970	Sohonos 1.5 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663974	Sohonos 10 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663978	Sohonos 2.5 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2
2663982	Sohonos 5 MG Oral Capsule	SY	67dce406-7cc4-4d66-92de-ad18b6df0625	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
15054-0010-1	15054001001	1 BLISTER PACK in 1 CARTON (15054-0010-1) / 14 CAPSULE in 1 BLISTER PACK	1 blister pack	2023-08-16	No	No	Current