Lumryz

Product NDC: 13551-004
11-digit product format: 135510004
Labeler code: 13551
Product ID: 13551-004_0aae7705-0d32-4900-8233-0b3da243bed6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium oxybate
Dosage form: FOR SUSPENSION, EXTENDED RELEASE
Route: ORAL
Labeler: Alkermes, Inc.
Application: NDA214755
Marketing category: NDA
Marketing start: 2023-05-01
Substance: SODIUM OXYBATE
Active strength: 9 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 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 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214755-001	LUMRYZ	4.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD, RS	2023-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-002	LUMRYZ	6GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-003	LUMRYZ	7.5GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-004	LUMRYZ	9GM/PACKET	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2023-05-01	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 53 · 2,107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214755-001	10272062	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	10736866	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	10952986	2037-07-21	U-3601		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	10973795	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11000498	2037-07-21	U-3580	Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11052061	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11065224	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11400065	2037-07-21	U-3579		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11504347	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11602512	2037-07-21	U-3577		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11602513	2037-07-21	U-3576		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11766418	2037-07-21		Drug product	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11839597	2037-07-21		Drug product	2024-01-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11896572	2037-07-21		Drug product	2024-02-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11986451	2037-07-21	U-3934		2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12097175	2037-07-21		Drug product	2024-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12097176	2037-07-21	U-4006		2024-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12109186	2037-07-21		Drug product	2024-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12115142	2037-07-21		Drug product	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12115143	2037-07-21		Drug product	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12115144	2037-07-21		Drug product	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12115145	2037-07-21		Drug product	2024-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12128021	2037-07-21	U-4022		2024-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12138239	2037-07-21		Drug product	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12144793	2037-07-21		Drug product	2024-11-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	12303478	2037-07-21	U-4189		2025-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11583510	2042-02-07	U-3578		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	11779557	2042-03-16	U-3705		2023-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	10272062	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	10736866	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	10952986	2037-07-21	U-3601		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	10973795	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11000498	2037-07-21	U-3580	Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11052061	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11065224	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11400065	2037-07-21	U-3579		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11504347	2037-07-21		Drug product	2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11602512	2037-07-21	U-3577		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11602513	2037-07-21	U-3576		2023-05-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	11766418	2037-07-21		Drug product	2023-09-29	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 236 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214755-001	NP	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	ODE-431	2030-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-001	ODE-494	2031-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	NP	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	ODE-431	2030-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-002	ODE-494	2031-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-003	NP	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-003	ODE-431	2030-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-003	ODE-494	2031-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-004	NP	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-004	ODE-431	2030-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214755-004	ODE-494	2031-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214755-001	NP	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-001	ODE-431	2030-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-001	ODE-494	2031-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-002	NP	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-002	ODE-431	2030-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-002	ODE-494	2031-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-003	NP	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-003	ODE-431	2030-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-003	ODE-494	2031-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-004	NP	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-004	ODE-431	2030-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214755-004	ODE-494	2031-10-16	`caaa826d4ba7…`
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…`

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: Lumryz
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM OXYBATE	9 g/1

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
13551-004-07	Lumryz	1 in 1 PACKET	FOR SUSPENSION, EXTENDED RELEASE	1	10
13551-004-07	Lumryz	7 in 1 CARTON	FOR SUSPENSION, EXTENDED RELEASE	7	10
13551-004-30	Lumryz	1 in 1 PACKET	FOR SUSPENSION, EXTENDED RELEASE	1	10
13551-004-30	Lumryz	30 in 1 CARTON	FOR SUSPENSION, EXTENDED RELEASE	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13551-004-07	EA - Each	13551-004	2e559fdd-9944-4cc4-8755-10542328051e	1	2023-06-06
13551-004-30	EA - Each	13551-004	3317b418-32f4-47bc-b23c-bd80c835142f	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13551-004	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

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
13551-004-07	13551000407	7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	7 packet	2023-05-01	No	No	Current
13551-004-30	13551000430	30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET	30 packet	2023-05-01	No	No	Current