Bylvay

Product NDC: 15054-3303
11-digit product format: 150543303
Labeler code: 15054
Product ID: 15054-3303_8caf9de8-b831-4bbf-91c1-12a269bee890
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: odevixibat
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Ipsen Biopharmaceuticals, Inc.
Application: NDA215498
Marketing category: NDA
Marketing start: 2024-01-10
Substance: ODEVIXIBAT
Active strength: 600 ug/1
Pharmacologic classes: Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215498-001	BYLVAY	ODEVIXIBAT	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20
N215498-002	BYLVAY	ODEVIXIBAT	0.4MG	CAPSULE / ORAL	RLD	2021-07-20
N215498-003	BYLVAY	ODEVIXIBAT	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20
N215498-004	BYLVAY	ODEVIXIBAT	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20

Orange Book patents#

Current patent rows page 1 of 2 · 112 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215498-001	10011633	2031-11-08	U-3186		2021-08-18
N215498-001	10011633	2031-11-08	U-3648		2021-08-18
N215498-001	10093697	2031-11-08	U-3186		2021-08-18
N215498-001	10093697	2031-11-08	U-3648		2021-08-18
N215498-001	10487111	2031-11-08	U-3186		2021-08-18
N215498-001	10487111	2031-11-08	U-3648		2021-08-18
N215498-001	10981952	2031-11-08	U-3186		2021-08-18
N215498-001	10981952	2031-11-08	U-3187		2021-08-18
N215498-001	10981952	2031-11-08	U-3648		2021-08-18
N215498-001	10981952	2031-11-08	U-3649		2021-08-18
N215498-001	11732006	2031-11-08	U-3186		2023-09-21
N215498-001	11732006	2031-11-08	U-3648		2023-09-21
N215498-001	12187812	2031-11-08	U-3186		2025-02-11
N215498-001	12187812	2031-11-08	U-3648		2025-02-11
N215498-001	12545705	2031-11-08	U-3186		2026-03-06
N215498-001	12545705	2031-11-08	U-3648		2026-03-06
N215498-001	9694018	2034-03-18	U-3186		2021-08-18
N215498-001	9694018	2034-03-18	U-3648		2021-08-18
N215498-001	10975046	2039-06-20		Drug substance	2021-08-18
N215498-001	11365182	2039-06-20	U-3186		2022-07-12
N215498-001	11365182	2039-06-20	U-3648		2022-07-12
N215498-001	11801226	2039-06-20		Drug product	2023-11-29
N215498-001	11802115	2039-06-20		Drug product	2023-11-29
N215498-001	12091394	2039-06-20		Drug substance	2024-10-17
N215498-001	12508234	2039-06-20	U-3186		2026-01-27
N215498-001	12508234	2039-06-20	U-3648		2026-01-27
N215498-001	11583539	2041-11-12	U-3186		2023-03-20
N215498-001	12447156	2041-11-12	U-3186		2025-11-19
N215498-002	10011633	2031-11-08	U-3186		2021-08-18
N215498-002	10011633	2031-11-08	U-3648		2021-08-18
N215498-002	10093697	2031-11-08	U-3186		2021-08-18
N215498-002	10093697	2031-11-08	U-3648		2021-08-18
N215498-002	10487111	2031-11-08	U-3186		2021-08-18
N215498-002	10487111	2031-11-08	U-3648		2021-08-18
N215498-002	10981952	2031-11-08	U-3186		2021-08-18
N215498-002	10981952	2031-11-08	U-3187		2021-08-18
N215498-002	10981952	2031-11-08	U-3648		2021-08-18
N215498-002	10981952	2031-11-08	U-3649		2021-08-18
N215498-002	11732006	2031-11-08	U-3186		2023-09-21
N215498-002	11732006	2031-11-08	U-3648		2023-09-21
N215498-002	12187812	2031-11-08	U-3186		2025-02-11
N215498-002	12187812	2031-11-08	U-3648		2025-02-11
N215498-002	12545705	2031-11-08	U-3186		2026-03-06
N215498-002	12545705	2031-11-08	U-3648		2026-03-06
N215498-002	9694018	2034-03-18	U-3186		2021-08-18
N215498-002	9694018	2034-03-18	U-3648		2021-08-18
N215498-002	10975046	2039-06-20		Drug substance	2021-08-18
N215498-002	11365182	2039-06-20	U-3186		2022-07-12
N215498-002	11365182	2039-06-20	U-3648		2022-07-12
N215498-002	11801226	2039-06-20		Drug product	2023-11-29
N215498-002	11802115	2039-06-20		Drug product	2023-11-29
N215498-002	12091394	2039-06-20		Drug substance	2024-10-17
N215498-002	12508234	2039-06-20	U-3186		2026-01-27
N215498-002	12508234	2039-06-20	U-3648		2026-01-27
N215498-002	11583539	2041-11-12	U-3186		2023-03-20
N215498-002	12447156	2041-11-12	U-3186		2025-11-19
N215498-003	10011633	2031-11-08	U-3186		2021-08-18
N215498-003	10011633	2031-11-08	U-3648		2021-08-18
N215498-003	10093697	2031-11-08	U-3186		2021-08-18
N215498-003	10093697	2031-11-08	U-3648		2021-08-18
N215498-003	10487111	2031-11-08	U-3186		2021-08-18
N215498-003	10487111	2031-11-08	U-3648		2021-08-18
N215498-003	10981952	2031-11-08	U-3186		2021-08-18
N215498-003	10981952	2031-11-08	U-3187		2021-08-18
N215498-003	10981952	2031-11-08	U-3648		2021-08-18
N215498-003	10981952	2031-11-08	U-3649		2021-08-18
N215498-003	11732006	2031-11-08	U-3186		2023-09-21
N215498-003	11732006	2031-11-08	U-3648		2023-09-21
N215498-003	12187812	2031-11-08	U-3186		2025-02-11
N215498-003	12187812	2031-11-08	U-3648		2025-02-11
N215498-003	12545705	2031-11-08	U-3186		2026-03-06
N215498-003	12545705	2031-11-08	U-3648		2026-03-06
N215498-003	9694018	2034-03-18	U-3186		2021-08-18
N215498-003	9694018	2034-03-18	U-3648		2021-08-18
N215498-003	10975046	2039-06-20		Drug substance	2021-08-18
N215498-003	11365182	2039-06-20	U-3186		2022-07-12
N215498-003	11365182	2039-06-20	U-3648		2022-07-12
N215498-003	11801226	2039-06-20		Drug product	2023-11-29
N215498-003	11802115	2039-06-20		Drug product	2023-11-29
N215498-003	12091394	2039-06-20		Drug substance	2024-10-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 16 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215498-001	I-918	2026-06-13
N215498-001	NCE	2026-07-20
N215498-001	ODE-363	2028-07-20
N215498-001	ODE-436	2030-06-13
N215498-002	I-918	2026-06-13
N215498-002	NCE	2026-07-20
N215498-002	ODE-363	2028-07-20
N215498-002	ODE-436	2030-06-13
N215498-003	I-918	2026-06-13
N215498-003	NCE	2026-07-20
N215498-003	ODE-363	2028-07-20
N215498-003	ODE-436	2030-06-13
N215498-004	I-918	2026-06-13
N215498-004	NCE	2026-07-20
N215498-004	ODE-363	2028-07-20
N215498-004	ODE-436	2030-06-13

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 4 · 132 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	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215498-001	BYLVAY	0.2MG	CAPSULE, PELLETS / ORAL	RLD	2021-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215498-002	BYLVAY	0.4MG	CAPSULE / ORAL	RLD	2021-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215498-003	BYLVAY	0.6MG	CAPSULE, PELLETS / ORAL	RLD, RS	2021-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215498-004	BYLVAY	1.2MG	CAPSULE / ORAL	RLD, RS	2021-07-20	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 77 · 3,056 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215498-001	10011633	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10011633	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10093697	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10093697	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10487111	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10487111	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3187		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10981952	2031-11-08	U-3649		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11732006	2031-11-08	U-3648		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11732006	2031-11-08	U-3186		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12187812	2031-11-08	U-3186		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12187812	2031-11-08	U-3648		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	9694018	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	9694018	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	10975046	2039-06-20		Drug substance	2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11365182	2039-06-20	U-3648		2022-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11365182	2039-06-20	U-3186		2022-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11801226	2039-06-20		Drug product	2023-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11802115	2039-06-20		Drug product	2023-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12091394	2039-06-20		Drug substance	2024-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12508234	2039-06-20	U-3186		2026-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12508234	2039-06-20	U-3648		2026-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	11583539	2041-11-12	U-3186		2023-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	12447156	2041-11-12	U-3186		2025-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10011633	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10011633	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10093697	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10093697	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10487111	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10487111	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3186		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3187		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3649		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	10981952	2031-11-08	U-3648		2021-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	11732006	2031-11-08	U-3648		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	11732006	2031-11-08	U-3186		2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	12187812	2031-11-08	U-3186		2025-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	12187812	2031-11-08	U-3648		2025-02-11	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 424 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	N215498-001	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-001	ODE-436	2030-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-002	ODE-436	2030-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-003	ODE-436	2030-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	I-918	2026-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	NCE	2026-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	ODE-363	2028-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215498-004	ODE-436	2030-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-001	ODE-436	2030-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-002	ODE-436	2030-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-003	ODE-436	2030-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	I-918	2026-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	NCE	2026-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	ODE-363	2028-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215498-004	ODE-436	2030-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215498-001	I-918	2026-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-001	NCE	2026-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-001	ODE-363	2028-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-001	ODE-436	2030-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	I-918	2026-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	NCE	2026-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	ODE-363	2028-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215498-002	ODE-436	2030-06-13	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ODEVIXIBAT	600 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2W150K0UUC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2563983	Internal RxNorm lookup
2563989	Internal RxNorm lookup
2563991	Internal RxNorm lookup
2563993	Internal RxNorm lookup
2563997	Internal RxNorm lookup
2564001	Internal RxNorm lookup
2564003	Internal RxNorm lookup
2564005	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
0935cd31-3251-4a0a-ac23-25ca4be12be9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f548ad1-0750-4bad-bb76-8e859974eef9	Product name	1	20220126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
15054-3303-1	Bylvay	30 in 1 BOTTLE	CAPSULE, COATED PELLETS	30		4
15054-3303-1	Bylvay	1 in 1 CARTON	CAPSULE, COATED PELLETS	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
15054-3303-1	EA - Each	15054-3303	4ae320e3-41da-4d29-a9ca-60251dfca304	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15054-3303	BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS BYLVAY (ODEVIXIBAT) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]	3	Current NDC, 2 package rows	20250328_0935cd31-3251-4a0a-ac23-25ca4be12be9.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
BYLVAY	ODEVIXIBAT	Albireo Pharma, Inc.	151f1d3e-2bf4-47ce-b1be-a892de3258fa	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215498 application number: NDA215498
Bylvay	ODEVIXIBAT	Ipsen Biopharmaceuticals, Inc.	0935cd31-3251-4a0a-ac23-25ca4be12be9	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215498 application number: NDA215498 ndc (product): 15054-3303

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2W150K0UUC	ODEVIXIBAT	501692-44-0	ODEVIXIBAT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2564005	Bylvay 1200 MCG Oral Capsule	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563989	Bylvay 200 MCG Oral Pellet	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564001	Bylvay 400 MCG Oral Capsule	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563993	Bylvay 600 MCG Oral Pellet	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564003	odevixibat 1200 MCG Oral Capsule	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563983	odevixibat 200 MCG Oral Pellet	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563997	odevixibat 400 MCG Oral Capsule	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563991	odevixibat 600 MCG Oral Pellet	PSN	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563989	odevixibat 0.2 MG Oral Pellet [Bylvay]	SBD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564001	odevixibat 0.4 MG Oral Capsule [Bylvay]	SBD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563993	odevixibat 0.6 MG Oral Pellet [Bylvay]	SBD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564005	odevixibat 1.2 MG Oral Capsule [Bylvay]	SBD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563983	odevixibat 0.2 MG Oral Pellet	SCD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563997	odevixibat 0.4 MG Oral Capsule	SCD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563991	odevixibat 0.6 MG Oral Pellet	SCD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564003	odevixibat 1.2 MG Oral Capsule	SCD	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563989	Bylvay 0.2 MG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564001	Bylvay 0.4 MG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563993	Bylvay 0.6 MG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564005	Bylvay 1.2 MG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564005	Bylvay 1200 MCG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563989	Bylvay 200 MCG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564001	Bylvay 400 MCG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563993	Bylvay 600 MCG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564003	odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563983	odevixibat (as odevixibat sesquihydrate) 200 MCG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563997	odevixibat (as odevixibat sesquihydrate) 400 MCG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563991	odevixibat (as odevixibat sesquihydrate) 600 MCG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2564003	odevixibat 1200 MCG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563983	odevixibat 200 MCG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563997	odevixibat 400 MCG Oral Capsule	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4
2563991	odevixibat 600 MCG Oral Pellet	SY	0935cd31-3251-4a0a-ac23-25ca4be12be9	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
15054-3303-1	15054330301	1 BOTTLE in 1 CARTON (15054-3303-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE	1 bottle	2024-01-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bylvay	Ipsen Biopharmaceuticals, Inc. \| Syngene International Limited. \| Almac Pharma Services Limited	2025-12-29	HUMAN PRESCRIPTION DRUG LABEL	4