Application 021196

Type: NDA
Sponsor: JAZZ PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYREM	SODIUM OXYBATE	SOLUTION;ORAL	500MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021196-001	XYREM	SODIUM OXYBATE	0.5GM/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021196-001	AA

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021196-001	10213400	2033-03-15	U-2499		2019-03-28
N021196-001	10864181	2033-03-15	U-1532		2021-01-13
N021196-001	11253494	2033-03-15	U-3323		2022-03-15
N021196-001	11253494	2033-03-15	U-3324		2022-03-15
N021196-001	11986446	2033-03-15	U-3324		2024-06-18
N021196-001	8772306	2033-03-15	U-1532		2014-07-09
N021196-001	9050302	2033-03-15	U-1532		2015-07-08
N021196-001	9486426	2033-03-15	U-1532		2016-12-06
N021196-001	10213400*PED	2033-09-15		Pediatric extension
N021196-001	10864181*PED	2033-09-15		Pediatric extension
N021196-001	11253494*PED	2033-09-15		Pediatric extension
N021196-001	8772306*PED	2033-09-15		Pediatric extension
N021196-001	9050302*PED	2033-09-15		Pediatric extension
N021196-001	9486426*PED	2033-09-15		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N021196-001	ODE-231	2025-10-26
N021196-001	PED	2026-04-26

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021196-001	XYREM	500MG/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021196-001	XYREM	500MG/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021196-001	XYREM	500MG/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021196-001	XYREM	500MG/ML	SOLUTION / ORAL	AA	RLD, RS	2002-07-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021196-001	XYREM	0.5GM/ML	SOLUTION / ORAL		RLD, RS	2002-07-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021196-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021196-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	AA	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	N021196-001	AA	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021196-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021196-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021196-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021196-001	AA	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 707 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021196-001	10213400	2033-03-15	U-2499		2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	10864181	2033-03-15	U-1532		2021-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	11253494	2033-03-15	U-3323		2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	11253494	2033-03-15	U-3324		2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	11986446	2033-03-15	U-3324		2024-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	8772306	2033-03-15	U-1532		2014-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	9050302	2033-03-15	U-1532		2015-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	9486426	2033-03-15	U-1532		2016-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	10213400*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	10864181*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	11253494*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	8772306*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	9050302*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	9486426*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021196-001	10213400	2033-03-15	U-2499		2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	10864181	2033-03-15	U-1532		2021-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	11253494	2033-03-15	U-3323		2022-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	11253494	2033-03-15	U-3324		2022-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	11986446	2033-03-15	U-3324		2024-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	8772306	2033-03-15	U-1532		2014-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	9050302	2033-03-15	U-1532		2015-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	9486426	2033-03-15	U-1532		2016-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	10213400*PED	2033-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	10864181*PED	2033-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	11253494*PED	2033-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	8772306*PED	2033-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	9050302*PED	2033-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	9486426*PED	2033-09-15		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	10213400	2033-03-15	U-2499		2019-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	10864181	2033-03-15	U-1532		2021-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	11253494	2033-03-15	U-3323		2022-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	11253494	2033-03-15	U-3324		2022-03-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	11986446	2033-03-15	U-3324		2024-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	8772306	2033-03-15	U-1532		2014-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	9050302	2033-03-15	U-1532		2015-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	9486426	2033-03-15	U-1532		2016-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	10213400*PED	2033-09-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	10864181*PED	2033-09-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	11253494*PED	2033-09-15		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	8772306*PED	2033-09-15		Pediatric extension		`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N021196-001	ODE-231	2025-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021196-001	PED	2026-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021196-001	ODE-231	2025-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021196-001	PED	2026-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	ODE-231	2025-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021196-001	PED	2026-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021196-001	ODE-231	2025-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021196-001	PED	2026-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021196-001	ODE-231	2025-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021196-001	PED	2026-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021196-001	ODE-231	2025-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021196-001	PED	2026-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021196-001	ODE-231	2025-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021196-001	PED	2026-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021196-001	ODE-231	2025-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021196-001	PED	2026-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021196-001	ODE-231	2025-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021196-001	PED	2026-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021196-001	ODE-231	2025-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021196-001	PED	2026-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021196-001	ODE-231	2025-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021196-001	PED	2026-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021196-001	ODE-231	2025-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021196-001	PED	2026-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021196-001	ODE-231	2025-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021196-001	PED	2026-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021196-001	ODE-231	2025-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021196-001	PED	2026-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021196-001	ODE-231	2025-10-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021196-001	PED	2026-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021196-001	PED	2022-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021196-001	ODE-231	2025-10-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021196-001	PED	2026-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021196-001	PED	2022-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021196-001	ODE-231	2025-10-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021196-001	PED	2026-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021196-001	PED	2022-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021196-001	ODE-231	2025-10-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021196-001	PED	2026-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021196-001	NPP	2021-10-26	`74a2ff9319b5…`

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
Xyrem	SODIUM OXYBATE	Jazz Pharmaceuticals, Inc.	926eb076-a4a8-45e4-91ef-411f0aa4f3ca	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021196 application number: NDA021196 ndc (product): 68727-100
sodium oxybate	SODIUM OXYBATE	Hikma Pharmaceuticals USA Inc.	bcef2c95-35e9-464d-9025-652acff769e7	2023-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021196 application number: NDA021196 ndc (product): 0054-9628

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-9628	N/A	sodium oxybate	Hikma Pharmaceuticals USA Inc.	NDA AUTHORIZED GENERIC	Current
68727-100	Xyrem	sodium oxybate	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-100	Xyrem	sodium oxybate	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-100	Xyrem	sodium oxybate	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-100	Xyrem	sodium oxybate	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-100	Xyrem	sodium oxybate	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-100	Xyrem	sodium oxybate	Jazz Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82975	SUPPL	2025-07-29
82299	SUPPL	2025-05-23
81435	SUPPL	2025-03-04
80244	SUPPL	2024-11-19
78548	SUPPL	2024-05-23
77234	SUPPL	2024-01-17
73969	SUPPL	2023-04-10
73968	SUPPL	2023-04-10
73950	SUPPL	2023-04-05
72312	SUPPL	2022-10-12
71890	SUPPL	2022-08-25
71889	SUPPL	2022-08-25
71857	SUPPL	2022-08-23
70138	SUPPL	2022-02-10
69543	SUPPL	2021-12-14
68369	SUPPL	2021-08-13
66236	SUPPL	2021-02-17
66227	SUPPL	2021-02-16
64755	SUPPL	2020-09-29
64754	SUPPL	2020-09-29
64722	SUPPL	2020-09-29
64001	SUPPL	2020-07-22
64000	SUPPL	2020-07-22
63999	SUPPL	2020-07-22
63998	SUPPL	2020-07-22
63997	SUPPL	2020-07-22
63996	SUPPL	2020-07-22
60056	SUPPL	2019-09-20
59980	SUPPL	2019-09-12
59971	SUPPL	2019-09-11
56139	SUPPL	2018-10-29
56118	SUPPL	2018-10-26
56117	SUPPL	2018-10-26
54059	SUPPL	2018-05-08
50450	SUPPL	2017-11-17
50436	SUPPL	2017-11-17
48960	SUPPL	2017-07-13
47012	SUPPL	2017-01-30
46991	SUPPL	2017-01-26
14621	SUPPL	2016-02-24
4611	SUPPL	2015-07-16
44473	ORIG	2015-07-07
4610	SUPPL	2015-03-02
36323	SUPPL	2014-04-14
27039	SUPPL	2014-04-14
27038	SUPPL	2012-12-20
44104	ORIG	2012-12-17
14620	SUPPL	2012-12-17
27037	SUPPL	2006-11-16
27036	SUPPL	2006-07-03
27034	SUPPL	2005-11-22
14619	SUPPL	2005-11-22
27035	SUPPL	2005-09-22
27033	SUPPL	2003-11-25
21503	ORIG	2002-07-17
14618	ORIG	2002-07-17
4609	ORIG	2002-07-17