Lumryz

Product NDC: 13551-003
11-digit product format: 135510003
Labeler code: 13551
Product ID: 13551-003_bd9a6c48-be50-44e5-8cbb-87cbaafe936d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium oxybate
Dosage form: FOR SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Avadel CNS Pharmaceuticals, LLC
Application: NDA214755
Marketing category: NDA
Marketing start: 2023-05-01
Substance: SODIUM OXYBATE
Active strength: 7.5 g/1
Pharmacologic classes: Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE]
DEA schedule: CIII
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
N214755-001	LUMRYZ	SODIUM OXYBATE	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01
N214755-002	LUMRYZ	SODIUM OXYBATE	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01
N214755-003	LUMRYZ	SODIUM OXYBATE	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01
N214755-004	LUMRYZ	SODIUM OXYBATE	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01

Orange Book patents#

Current patent rows page 1 of 2 · 113 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214755-001	10272062	2037-07-21		Drug product	2023-05-23
N214755-001	10736866	2037-07-21		Drug product	2023-05-23
N214755-001	10952986	2037-07-21	U-3601		2023-05-23
N214755-001	10973795	2037-07-21		Drug product	2023-05-23
N214755-001	11000498	2037-07-21	U-3580	Drug product	2023-05-23
N214755-001	11052061	2037-07-21		Drug product	2023-05-23
N214755-001	11065224	2037-07-21		Drug product	2023-05-23
N214755-001	11400065	2037-07-21	U-3579		2023-05-23
N214755-001	11504347	2037-07-21		Drug product	2023-05-23
N214755-001	11602512	2037-07-21	U-3577		2023-05-23
N214755-001	11602513	2037-07-21	U-3576		2023-05-23
N214755-001	11766418	2037-07-21		Drug product	2023-09-29
N214755-001	11839597	2037-07-21		Drug product	2024-01-04
N214755-001	11896572	2037-07-21		Drug product	2024-02-20
N214755-001	11986451	2037-07-21	U-3934		2024-05-29
N214755-001	12097175	2037-07-21		Drug product	2024-10-15
N214755-001	12097176	2037-07-21	U-4006		2024-10-15
N214755-001	12109186	2037-07-21		Drug product	2024-10-15
N214755-001	12115142	2037-07-21		Drug product	2024-10-22
N214755-001	12115143	2037-07-21		Drug product	2024-10-22
N214755-001	12115144	2037-07-21		Drug product	2024-10-22
N214755-001	12115145	2037-07-21		Drug product	2024-10-22
N214755-001	12128021	2037-07-21	U-4022		2024-11-12
N214755-001	12138239	2037-07-21		Drug product	2024-11-15
N214755-001	12144793	2037-07-21		Drug product	2024-11-22
N214755-001	12303478	2037-07-21	U-4189		2025-06-02
N214755-001	11583510	2042-02-07	U-3578		2023-05-23
N214755-001	11779557	2042-03-16	U-3705		2023-10-24
N214755-002	10272062	2037-07-21		Drug product	2023-05-23
N214755-002	10736866	2037-07-21		Drug product	2023-05-23
N214755-002	10952986	2037-07-21	U-3601		2023-05-23
N214755-002	10973795	2037-07-21		Drug product	2023-05-23
N214755-002	11000498	2037-07-21	U-3580	Drug product	2023-05-23
N214755-002	11052061	2037-07-21		Drug product	2023-05-23
N214755-002	11065224	2037-07-21		Drug product	2023-05-23
N214755-002	11400065	2037-07-21	U-3579		2023-05-23
N214755-002	11504347	2037-07-21		Drug product	2023-05-23
N214755-002	11602512	2037-07-21	U-3577		2023-05-23
N214755-002	11602513	2037-07-21	U-3576		2023-05-23
N214755-002	11766418	2037-07-21		Drug product	2023-09-29
N214755-002	11826335	2037-07-21	U-3751		2023-12-04
N214755-002	11839597	2037-07-21		Drug product	2024-01-04
N214755-002	11896572	2037-07-21		Drug product	2024-02-20
N214755-002	11986451	2037-07-21	U-3934		2024-05-29
N214755-002	12097175	2037-07-21		Drug product	2024-10-15
N214755-002	12097176	2037-07-21	U-4006		2024-10-15
N214755-002	12109186	2037-07-21		Drug product	2024-10-15
N214755-002	12115142	2037-07-21		Drug product	2024-10-22
N214755-002	12115143	2037-07-21		Drug product	2024-10-22
N214755-002	12115144	2037-07-21		Drug product	2024-10-22
N214755-002	12115145	2037-07-21		Drug product	2024-10-22
N214755-002	12128021	2037-07-21	U-4022		2024-11-12
N214755-002	12138239	2037-07-21		Drug product	2024-11-15
N214755-002	12144793	2037-07-21		Drug product	2024-11-22
N214755-002	12303478	2037-07-21	U-4189		2025-06-02
N214755-002	11583510	2042-02-07	U-3578		2023-05-23
N214755-002	11779557	2042-03-16	U-3705		2023-10-24
N214755-003	10272062	2037-07-21		Drug product	2023-05-23
N214755-003	10736866	2037-07-21		Drug product	2023-05-23
N214755-003	10952986	2037-07-21	U-3601		2023-05-23
N214755-003	10973795	2037-07-21		Drug product	2023-05-23
N214755-003	11000498	2037-07-21	U-3580	Drug product	2023-05-23
N214755-003	11052061	2037-07-21		Drug product	2023-05-23
N214755-003	11065224	2037-07-21		Drug product	2023-05-23
N214755-003	11400065	2037-07-21	U-3579		2023-05-23
N214755-003	11504347	2037-07-21		Drug product	2023-05-23
N214755-003	11602512	2037-07-21	U-3577		2023-05-23
N214755-003	11602513	2037-07-21	U-3576		2023-05-23
N214755-003	11766418	2037-07-21		Drug product	2023-09-29
N214755-003	11839597	2037-07-21		Drug product	2024-01-04
N214755-003	11896572	2037-07-21		Drug product	2024-02-20
N214755-003	11986451	2037-07-21	U-3934		2024-05-29
N214755-003	12097175	2037-07-21		Drug product	2024-10-15
N214755-003	12097176	2037-07-21	U-4006		2024-10-15
N214755-003	12109186	2037-07-21		Drug product	2024-10-15
N214755-003	12115142	2037-07-21		Drug product	2024-10-22
N214755-003	12115143	2037-07-21		Drug product	2024-10-22
N214755-003	12115144	2037-07-21		Drug product	2024-10-22
N214755-003	12115145	2037-07-21		Drug product	2024-10-22
N214755-003	12128021	2037-07-21	U-4022		2024-11-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214755-001	NP	2026-05-01
N214755-001	ODE-431	2030-05-01
N214755-001	ODE-494	2031-10-16
N214755-002	NP	2026-05-01
N214755-002	ODE-431	2030-05-01
N214755-002	ODE-494	2031-10-16
N214755-003	NP	2026-05-01
N214755-003	ODE-431	2030-05-01
N214755-003	ODE-494	2031-10-16
N214755-004	NP	2026-05-01
N214755-004	ODE-431	2030-05-01
N214755-004	ODE-494	2031-10-16

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 · 88 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	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 48 · 1,881 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	N214755-001	10272062	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10736866	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10952986	2037-07-21	U-3601		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10973795	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11000498	2037-07-21	U-3580	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11052061	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11065224	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11400065	2037-07-21	U-3579		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11504347	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11602512	2037-07-21	U-3577		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11602513	2037-07-21	U-3576		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11766418	2037-07-21		Drug product	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11839597	2037-07-21		Drug product	2024-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11896572	2037-07-21		Drug product	2024-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11986451	2037-07-21	U-3934		2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12097175	2037-07-21		Drug product	2024-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12097176	2037-07-21	U-4006		2024-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12109186	2037-07-21		Drug product	2024-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115142	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115143	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115144	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12115145	2037-07-21		Drug product	2024-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12128021	2037-07-21	U-4022		2024-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12138239	2037-07-21		Drug product	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12144793	2037-07-21		Drug product	2024-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12226377	2037-07-21		Drug product	2025-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	12303478	2037-07-21	U-4189		2025-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	10925844	2040-02-28		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11583510	2042-02-07	U-3578		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	11779557	2042-03-16	U-3705		2023-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10272062	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10736866	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10952986	2037-07-21	U-3601		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	10973795	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11000498	2037-07-21	U-3580	Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11052061	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11065224	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11400065	2037-07-21	U-3579		2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11504347	2037-07-21		Drug product	2023-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	11602512	2037-07-21	U-3577		2023-05-23	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 212 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	N214755-001	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-001	ODE-494	2031-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-002	ODE-494	2031-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-003	ODE-494	2031-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	NP	2026-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	ODE-431	2030-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214755-004	ODE-494	2031-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-001	ODE-494	2031-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-002	ODE-494	2031-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-003	ODE-494	2031-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	NP	2026-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	ODE-431	2030-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214755-004	ODE-494	2031-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214755-001	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-001	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-001	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-002	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-003	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	NP	2026-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	ODE-431	2030-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214755-004	ODE-494	2031-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	NP	2026-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	ODE-431	2030-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-001	ODE-494	2031-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214755-002	NP	2026-05-01	`fd3edfee7708…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM OXYBATE	7.5 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7G33012534	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2636822	Internal RxNorm lookup
2636828	Internal RxNorm lookup
2636830	Internal RxNorm lookup
2636832	Internal RxNorm lookup
2636834	Internal RxNorm lookup
2636836	Internal RxNorm lookup
2636838	Internal RxNorm lookup
2636840	Internal RxNorm lookup
2698135	Internal RxNorm lookup
2698136	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
10e5e40c-52f3-4c73-8a34-2c29c690a934	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e88548e-cd6c-4b2e-a954-1bb23670f612	Product name	1	20231010
b3e31acf-ce79-4bd9-845e-03c8d973021a	Product name	1	20210203
a3ec038e-96ea-8cce-3e80-6c56853019f6	Product name	2	20170424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13551-003-07	Lumryz	1 in 1 PACKET	FOR SUSPENSION, EXTENDED RELEASE	1	10
13551-003-07	Lumryz	7 in 1 CARTON	FOR SUSPENSION, EXTENDED RELEASE	7	10
13551-003-30	Lumryz	30 in 1 CARTON	FOR SUSPENSION, EXTENDED RELEASE	30	10
13551-003-30	Lumryz	1 in 1 PACKET	FOR SUSPENSION, EXTENDED RELEASE	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13551-003-07	EA - Each	13551-003	3ed520ff-ae1e-47fc-8f3a-c5bf4d3a74ef	1	2023-06-06
13551-003-30	EA - Each	13551-003	b9946d84-0eab-4677-8d23-6f0e34d9f44c	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13551-003	LUMRYZ (SODIUM OXYBATE) FOR SUSPENSION, EXTENDED RELEASE LUMRYZ (SODIUM OXYBATE) KIT [AVADEL CNS PHARMACEUTICALS, LLC]	8	Current NDC, 4 package rows	20250416_10e5e40c-52f3-4c73-8a34-2c29c690a934.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
Lumryz	SODIUM OXYBATE	Avadel CNS Pharmaceuticals, LLC	10e5e40c-52f3-4c73-8a34-2c29c690a934	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 214755 application number: NDA214755 ndc (product): 13551-003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7G33012534	SODIUM OXYBATE	502-85-2	SODIUM OXYBATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2698136	{7 (sodium oxybate 4500 MG Granules for Oral Suspension [Lumryz]) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension [Lumryz]) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension [Lumryz]) } Pack [Lumryz 28-Day Starter Pack]	BPCK	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2698135	{7 (sodium oxybate 4500 MG Granules for Oral Suspension) / 14 (sodium oxybate 6000 MG Granules for Oral Suspension) / 7 (sodium oxybate 7500 MG Granules for Oral Suspension) } Pack	GPCK	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2698136	Lumryz 28-Day Starter Pack	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636828	Lumryz 4.5 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636832	Lumryz 6 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636836	Lumryz 7.5 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636840	Lumryz 9 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2698135	sodium oxybate 28-Day Starter Pack	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636822	sodium oxybate 4.5 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636830	sodium oxybate 6 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636834	sodium oxybate 7.5 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636838	sodium oxybate 9 GM Granules for extended release Oral Suspension	PSN	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636828	sodium oxybate 4500 MG Granules for Oral Suspension [Lumryz]	SBD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636832	sodium oxybate 6000 MG Granules for Oral Suspension [Lumryz]	SBD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636836	sodium oxybate 7500 MG Granules for Oral Suspension [Lumryz]	SBD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636840	sodium oxybate 9000 MG Granules for Oral Suspension [Lumryz]	SBD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636822	sodium oxybate 4500 MG Granules for Oral Suspension	SCD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636830	sodium oxybate 6000 MG Granules for Oral Suspension	SCD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636834	sodium oxybate 7500 MG Granules for Oral Suspension	SCD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636838	sodium oxybate 9000 MG Granules for Oral Suspension	SCD	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2698136	Lumryz 28-Day Starter Pack	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636828	Lumryz 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636828	Lumryz 4500 MG Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636832	Lumryz 6 GM (equivalent to 5 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636832	Lumryz 6000 MG Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636836	Lumryz 7.5 GM (equivalent to 6.2 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636836	Lumryz 7500 MG Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636840	Lumryz 9 GM (equivalent to 7.4 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636840	Lumryz 9000 MG Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2698135	sodium oxybate 28-Day Starter Pack	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636822	sodium oxybate 4.5 GM (equivalent to 3.7 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636830	sodium oxybate 6 GM (equivalent to 5 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636834	sodium oxybate 7.5 GM (equivalent to 6.2 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10
2636838	sodium oxybate 9 GM (equivalent to 7.4 GM oxybate) Granules for Oral Suspension	SY	10e5e40c-52f3-4c73-8a34-2c29c690a934	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
13551-003-07	13551000307	7 PACKET in 1 CARTON (13551-003-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	7 packet	2023-05-01	No	No	Current
13551-003-30	13551000330	30 PACKET in 1 CARTON (13551-003-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	30 packet	2023-05-01	No	No	Current