SOHONOS

Product NDC: 15054-0100
11-digit product format: 150540100
Labeler code: 15054
Product ID: 15054-0100_5bd9a571-7061-4cc7-bda8-18a9976dd427
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: 10 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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	10864194	2037-06-08	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
N215559-002	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	10864194	2037-06-08	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
N215559-003	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	10864194	2037-06-08	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
N215559-004	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	10864194	2037-06-08	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
N215559-005	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	10864194	2037-06-08	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

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 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-001	SOHONOS	1MG	CAPSULE / ORAL	RLD	2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-002	SOHONOS	1.5MG	CAPSULE / ORAL	RLD	2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-003	SOHONOS	2.5MG	CAPSULE / ORAL	RLD	2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-004	SOHONOS	5MG	CAPSULE / ORAL	RLD	2023-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215559-005	SOHONOS	10MG	CAPSULE / ORAL	RLD, RS	2023-08-16	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 640 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215559-001	10292954	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	12023312	2031-08-31	U-3966	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	9314439	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	9789074	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	10864194	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	11622959	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	12138245	2037-06-08	U-4031	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	12201614	2037-06-08	U-4031	2025-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	12458626	2037-06-08	U-3676	2025-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	10292954	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	12023312	2031-08-31	U-3966	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	9314439	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	9789074	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	10864194	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	11622959	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	12138245	2037-06-08	U-4031	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	12201614	2037-06-08	U-4031	2025-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	12458626	2037-06-08	U-3676	2025-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	10292954	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	12023312	2031-08-31	U-3966	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	9314439	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	9789074	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	10864194	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	11622959	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	12138245	2037-06-08	U-4031	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	12201614	2037-06-08	U-4031	2025-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	12458626	2037-06-08	U-3676	2025-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	10292954	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	12023312	2031-08-31	U-3966	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	9314439	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	9789074	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	10864194	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	11622959	2037-06-08	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	12138245	2037-06-08	U-4031	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	12201614	2037-06-08	U-4031	2025-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	12458626	2037-06-08	U-3676	2025-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	10292954	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	12023312	2031-08-31	U-3966	2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	9314439	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	9789074	2031-08-31	U-3676	2023-09-07	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215559-001	NCE	2028-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-001	ODE-439	2030-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	NCE	2028-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-002	ODE-439	2030-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	NCE	2028-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-003	ODE-439	2030-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	NCE	2028-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-004	ODE-439	2030-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	NCE	2028-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215559-005	ODE-439	2030-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-001	NCE	2028-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-001	ODE-439	2030-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-002	NCE	2028-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-002	ODE-439	2030-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-003	NCE	2028-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-003	ODE-439	2030-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-004	NCE	2028-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-004	ODE-439	2030-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-005	NCE	2028-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215559-005	ODE-439	2030-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215559-001	NCE	2028-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-001	ODE-439	2030-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-002	NCE	2028-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-002	ODE-439	2030-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-003	NCE	2028-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-003	ODE-439	2030-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-004	NCE	2028-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-004	ODE-439	2030-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-005	NCE	2028-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215559-005	ODE-439	2030-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-001	NCE	2028-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-001	ODE-439	2030-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-002	NCE	2028-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-002	ODE-439	2030-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-003	NCE	2028-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-003	ODE-439	2030-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-004	NCE	2028-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-004	ODE-439	2030-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-005	NCE	2028-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215559-005	ODE-439	2030-08-16	`fd3edfee7708…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALOVAROTENE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
28K6I5M16G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2663960	Internal RxNorm lookup
2663966	Internal RxNorm lookup
2663968	Internal RxNorm lookup
2663970	Internal RxNorm lookup
2663972	Internal RxNorm lookup
2663974	Internal RxNorm lookup
2663976	Internal RxNorm lookup
2663978	Internal RxNorm lookup
2663980	Internal RxNorm lookup
2663982	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
67dce406-7cc4-4d66-92de-ad18b6df0625	Available on FDA.report

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
15054-0100-1	SOHONOS	1 in 1 CARTON	CAPSULE	1		2
15054-0100-1	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
15054-0100-1	EA - Each	15054-0100	8a249be1-ebcc-442b-8f15-b911cb2ed299	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15054-0100	SOHONOS (PALOVAROTENE) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]	2	Current NDC, 2 package rows	20250323_67dce406-7cc4-4d66-92de-ad18b6df0625.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SOHONOS	PALOVAROTENE	Ipsen Biopharmaceuticals, Inc.	67dce406-7cc4-4d66-92de-ad18b6df0625	2025-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215559 application number: NDA215559 ndc (product): 15054-0100

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
15054-0100-1	15054010001	1 BLISTER PACK in 1 CARTON (15054-0100-1) / 14 CAPSULE in 1 BLISTER PACK	1 blister pack	2023-08-16	No	No	Current