XYWAV

Product NDC: 68727-150
11-digit product format: 687270150
Labeler code: 68727
Product ID: 68727-150_6815ce2b-51e5-4d03-92a6-523718ab0d8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: calcium, magnesium, potassium, and sodium oxybates
Dosage form: SOLUTION
Route: ORAL
Labeler: Jazz Pharmaceuticals, Inc.
Application: NDA212690
Marketing category: NDA
Marketing start: 2020-11-02
Substance: CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE
Active strength: .5; .5; .5; .5 g/mL; g/mL; g/mL; g/mL
Pharmacologic classes: Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [PE], Decreased Central Nervous System Organized Electrical Activity [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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212690-001	XYWAV	CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL		RLD, RS	2020-07-21

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212690-001	10195168	2033-01-11		Drug product	2020-08-19
N212690-001	10675258	2033-01-11	U-2938		2020-08-19
N212690-001	11554102	2033-01-11		Drug product	2023-02-08
N212690-001	8591922	2033-01-11		Drug product	2020-08-19
N212690-001	8901173	2033-01-11		Drug product	2020-08-19
N212690-001	9132107	2033-01-11		Drug product	2020-08-19
N212690-001	10213400	2033-03-15	U-2499		2020-08-19
N212690-001	10864181	2033-03-15	U-3017		2021-01-13
N212690-001	11253494	2033-03-15	U-3323		2022-03-15
N212690-001	11253494	2033-03-15	U-3324		2022-03-15
N212690-001	11986446	2033-03-15	U-3017		2024-06-18
N212690-001	11986446	2033-03-15	U-3324		2024-06-18
N212690-001	8772306	2033-03-15	U-1532		2020-08-19
N212690-001	8772306	2033-03-15	U-3198		2020-08-19
N212690-001	9050302	2033-03-15	U-1532		2020-08-19
N212690-001	9486426	2033-03-15	U-1532		2020-08-19
N212690-001	10213400*PED	2033-09-15		Pediatric extension
N212690-001	10864181*PED	2033-09-15		Pediatric extension
N212690-001	11253494*PED	2033-09-15		Pediatric extension
N212690-001	8772306*PED	2033-09-15		Pediatric extension
N212690-001	9050302*PED	2033-09-15		Pediatric extension
N212690-001	9486426*PED	2033-09-15		Pediatric extension
N212690-001	11426373	2037-09-19	U-3432		2022-09-27
N212690-001	12138233	2041-02-22	U-4044		2024-12-11
N212690-001	12582622	2041-02-22	U-4044		2026-04-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212690-001	ODE-361	2027-07-21
N212690-001	PED	2028-01-21
N212690-001	ODE-369	2028-08-12

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.

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	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 782 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	N212690-001	10195168	2033-01-11		Drug product	2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	10675258	2033-01-11	U-2938		2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11554102	2033-01-11		Drug product	2023-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	8591922	2033-01-11		Drug product	2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	8901173	2033-01-11		Drug product	2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	9132107	2033-01-11		Drug product	2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	10213400	2033-03-15	U-2499		2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	10864181	2033-03-15	U-3017		2021-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11253494	2033-03-15	U-3323		2022-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11253494	2033-03-15	U-3324		2022-03-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11986446	2033-03-15	U-3017		2024-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11986446	2033-03-15	U-3324		2024-06-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	8772306	2033-03-15	U-3198		2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	8772306	2033-03-15	U-1532		2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	9050302	2033-03-15	U-1532		2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	9486426	2033-03-15	U-1532		2020-08-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	10213400*PED	2033-09-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	10864181*PED	2033-09-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11253494*PED	2033-09-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	8772306*PED	2033-09-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	9050302*PED	2033-09-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	9486426*PED	2033-09-15		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	11426373	2037-09-19	U-3432		2022-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	12138233	2041-02-22	U-4044		2024-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	12582622	2041-02-22	U-4044		2026-04-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212690-001	10195168	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10675258	2033-01-11	U-2938		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11554102	2033-01-11		Drug product	2023-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8591922	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8901173	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9132107	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10213400	2033-03-15	U-2499		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10864181	2033-03-15	U-3017		2021-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11253494	2033-03-15	U-3323		2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11253494	2033-03-15	U-3324		2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11986446	2033-03-15	U-3017		2024-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11986446	2033-03-15	U-3324		2024-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8772306	2033-03-15	U-3198		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8772306	2033-03-15	U-1532		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9050302	2033-03-15	U-1532		2020-08-19	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 130 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	N212690-001	ODE-361	2027-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	PED	2028-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212690-001	ODE-369	2028-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212690-001	ODE-361	2027-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	PED	2028-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	ODE-369	2028-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212690-001	ODE-361	2027-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	PED	2028-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	ODE-369	2028-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	ODE-361	2027-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	PED	2028-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	ODE-369	2028-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212690-001	ODE-361	2027-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212690-001	PED	2028-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212690-001	ODE-369	2028-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	ODE-361	2027-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	PED	2028-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	ODE-369	2028-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	ODE-361	2027-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	PED	2028-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	ODE-369	2028-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	I-870	2024-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	ODE-361	2027-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	PED	2028-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	ODE-369	2028-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	I-870	2024-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	ODE-361	2027-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	PED	2028-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	ODE-369	2028-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	I-870	2024-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	ODE-361	2027-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	PED	2028-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	ODE-369	2028-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	I-870	2024-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	ODE-361	2027-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	PED	2028-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	ODE-369	2028-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212690-001	I-870	2024-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212690-001	ODE-361	2027-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212690-001	PED	2028-01-21	`d06236e962d9…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM OXYBATE	.5 g/mL
CALCIUM OXYBATE	.5 g/mL
POTASSIUM OXYBATE	.5 g/mL
MAGNESIUM OXYBATE	.5 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7G33012534	Internal UNII lookup
8W24SYD6ZI	Internal UNII lookup
S8NKF3H3KT	Internal UNII lookup
G983HLV265	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2393794	Internal RxNorm lookup
2393795	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
1e0ae43a-037f-42af-8e23-a0e51d75abe8	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	Strength	SPL version
68727-150-01	XYWAV	180 mL in 1 BOTTLE, PLASTIC	SOLUTION	180		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68727-150	XYWAV (CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES) SOLUTION [JAZZ PHARMACEUTICALS, INC.]	14	Current NDC, Legacy NDC, 1 package rows	20241010_1e0ae43a-037f-42af-8e23-a0e51d75abe8.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
XYWAV	CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES	Jazz Pharmaceuticals, Inc.	1e0ae43a-037f-42af-8e23-a0e51d75abe8	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212690 application number: NDA212690 ndc (product): 68727-150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8W24SYD6ZI	CALCIUM OXYBATE	82316-97-0	CALCIUM OXYBATE
G983HLV265	MAGNESIUM OXYBATE	82316-98-1	MAGNESIUM OXYBATE
S8NKF3H3KT	POTASSIUM OXYBATE	57769-01-4	POTASSIUM OXYBATE
7G33012534	SODIUM OXYBATE	502-85-2	SODIUM OXYBATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2393795	calcium / magnesium / potassium / sodium oxybates 0.5 GM in 1 mL Oral Solution	PSN	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393794	xywav 0.5 GM in 1 mL Oral Solution	PSN	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393794	calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / potassium oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]	SBD	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393795	calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / potassium oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution	SCD	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393795	calcium oxybate 0.234 GM / magnesium oxybate 0.096 GM / potassium oxybate 0.13 GM / sodium oxybate 0.04 GM per 1 ML Oral Solution	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393795	calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / K+ oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393794	calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / K+ oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393795	calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / Pot oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393794	calcium oxybate 234 MG/ML / magnesium oxybate 96 MG/ML / Pot oxybate 130 MG/ML / sodium oxybate 40 MG/ML Oral Solution [Xywav]	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393795	calcium/magnesium/potassium/sodium oxybates 0.5 GM per 1 ML Oral Solution	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393794	Xywav (calcium oxybate 0.234 GM / magnesium oxybate 0.096 GM / potassium oxybate 0.13 GM / sodium oxybate 0.04 GM) per 1 ML Oral Solution	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16
2393794	Xywav 0.5 GM per 1 ML Oral Solution	SY	1e0ae43a-037f-42af-8e23-a0e51d75abe8	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68727-150-01	68727015001	180 mL in 1 BOTTLE, PLASTIC (68727-150-01)	180 ml	2020-11-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XYWAV	Jazz Pharmaceuticals, Inc. \| Jazz Pharmaceuticals Ireland Limited	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	16