Application 022496

Type: NDA
Sponsor: PACIRA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXPAREL	BUPIVACAINE	INJECTABLE, LIPOSOMAL;INJECTION	133MG/10ML (13.3MG/ML)	Yes	Yes
002	EXPAREL	BUPIVACAINE	INJECTABLE, LIPOSOMAL;INJECTION	266MG/20ML (13.3MG/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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022496-001	EXPAREL	BUPIVACAINE	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28
N022496-002	EXPAREL	BUPIVACAINE	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28

Orange Book patents#

Current patent rows page 1 of 1 · 48 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022496-001	11033495	2041-01-22	U-3182	Drug product	2021-07-30
N022496-001	11179336	2041-01-22	U-3250	Drug product	2021-11-30
N022496-001	11278494	2041-01-22	U-3250	Drug product	2022-04-04
N022496-001	11304904	2041-01-22	U-3346	Drug product	2022-04-21
N022496-001	11311486	2041-01-22	U-3250	Drug product	2022-04-27
N022496-001	11357727	2041-01-22	U-3380	Drug product	2022-06-16
N022496-001	11426348	2041-01-22	U-3380	Drug product	2022-09-02
N022496-001	11452691	2041-01-22	U-3439	Drug product	2022-10-04
N022496-001	11819574	2041-01-22	U-3250	Drug product	2023-12-06
N022496-001	11819575	2041-01-22	U-3250	Drug product	2023-12-06
N022496-001	11925706	2041-01-22	U-3380	Drug product	2024-03-15
N022496-001	12144890	2041-01-22	U-4033	Drug product	2024-11-20
N022496-001	12151024	2041-01-22	U-4037	Drug product	2024-11-26
N022496-001	12296047	2041-01-22	U-4184	Drug product	2025-05-20
N022496-001	11931459	2042-03-17	U-3839		2024-03-20
N022496-001	11931459	2042-03-17	U-3840		2024-03-20
N022496-001	11918565	2043-02-02	U-3841		2024-03-20
N022496-001	12226610	2043-02-02	U-4148		2025-03-14
N022496-001	12226610	2043-02-02	U-4149		2025-03-14
N022496-001	12226610	2043-02-02	U-4150		2025-03-14
N022496-001	12156940	2044-07-02		Drug product	2024-12-03
N022496-001	12251468	2044-07-02	U-4152	Drug product	2025-03-21
N022496-001	12318483	2044-07-02	U-4152		2025-06-11
N022496-001	12370142	2044-07-02	U-4152	Drug product	2025-08-07
N022496-002	11033495	2041-01-22	U-3182	Drug product	2021-07-30
N022496-002	11179336	2041-01-22	U-3250	Drug product	2021-11-30
N022496-002	11278494	2041-01-22	U-3250	Drug product	2022-04-04
N022496-002	11304904	2041-01-22	U-3346	Drug product	2022-04-21
N022496-002	11311486	2041-01-22	U-3250	Drug product	2022-04-27
N022496-002	11357727	2041-01-22	U-3380	Drug product	2022-06-16
N022496-002	11426348	2041-01-22	U-3380	Drug product	2022-09-02
N022496-002	11452691	2041-01-22	U-3439	Drug product	2022-10-04
N022496-002	11819574	2041-01-22	U-3250	Drug product	2023-12-06
N022496-002	11819575	2041-01-22	U-3250	Drug product	2023-12-06
N022496-002	11925706	2041-01-22	U-3380	Drug product	2024-03-15
N022496-002	12144890	2041-01-22	U-4033	Drug product	2024-11-20
N022496-002	12151024	2041-01-22	U-4037	Drug product	2024-11-26
N022496-002	12296047	2041-01-22	U-4184	Drug product	2025-05-20
N022496-002	11931459	2042-03-17	U-3839		2024-03-20
N022496-002	11931459	2042-03-17	U-3840		2024-03-20
N022496-002	11918565	2043-02-02	U-3841		2024-03-20
N022496-002	12226610	2043-02-02	U-4148		2025-03-14
N022496-002	12226610	2043-02-02	U-4149		2025-03-14
N022496-002	12226610	2043-02-02	U-4150		2025-03-14
N022496-002	12156940	2044-07-02		Drug product	2024-12-03
N022496-002	12251468	2044-07-02	U-4152	Drug product	2025-03-21
N022496-002	12318483	2044-07-02	U-4152		2025-06-11
N022496-002	12370142	2044-07-02	U-4152	Drug product	2025-08-07

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022496-001	I-929	2026-11-09
N022496-002	I-929	2026-11-09

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 · 84 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	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION	AP	RLD, RS	2011-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022496-001	EXPAREL	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022496-002	EXPAREL	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	2011-10-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N022496-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022496-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022496-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022496-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022496-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022496-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022496-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022496-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-002	AP	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 826 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	N022496-001	11033495	2041-01-22	U-3182	Drug product	2021-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11179336	2041-01-22	U-3250	Drug product	2021-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11278494	2041-01-22	U-3250	Drug product	2022-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11304904	2041-01-22	U-3346	Drug product	2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11311486	2041-01-22	U-3250	Drug product	2022-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11357727	2041-01-22	U-3380	Drug product	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11426348	2041-01-22	U-3380	Drug product	2022-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11452691	2041-01-22	U-3439	Drug product	2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11819574	2041-01-22	U-3250	Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11819575	2041-01-22	U-3250	Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11925706	2041-01-22	U-3380	Drug product	2024-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12144890	2041-01-22	U-4033	Drug product	2024-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12151024	2041-01-22	U-4037	Drug product	2024-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12296047	2041-01-22	U-4184	Drug product	2025-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11931459	2042-03-17	U-3839		2024-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11931459	2042-03-17	U-3840		2024-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	11918565	2043-02-02	U-3841		2024-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12226610	2043-02-02	U-4148		2025-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12226610	2043-02-02	U-4149		2025-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12226610	2043-02-02	U-4150		2025-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12156940	2044-07-02		Drug product	2024-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12251468	2044-07-02	U-4152	Drug product	2025-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12318483	2044-07-02	U-4152		2025-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-001	12370142	2044-07-02	U-4152	Drug product	2025-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11033495	2041-01-22	U-3182	Drug product	2021-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11179336	2041-01-22	U-3250	Drug product	2021-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11278494	2041-01-22	U-3250	Drug product	2022-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11304904	2041-01-22	U-3346	Drug product	2022-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11311486	2041-01-22	U-3250	Drug product	2022-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11357727	2041-01-22	U-3380	Drug product	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11426348	2041-01-22	U-3380	Drug product	2022-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11452691	2041-01-22	U-3439	Drug product	2022-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11819574	2041-01-22	U-3250	Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11819575	2041-01-22	U-3250	Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11925706	2041-01-22	U-3380	Drug product	2024-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	12144890	2041-01-22	U-4033	Drug product	2024-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	12151024	2041-01-22	U-4037	Drug product	2024-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	12296047	2041-01-22	U-4184	Drug product	2025-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11931459	2042-03-17	U-3840		2024-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	11931459	2042-03-17	U-3839		2024-03-20	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 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	N022496-001	I-929	2026-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022496-002	I-929	2026-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022496-001	I-929	2026-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022496-002	I-929	2026-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022496-001	I-929	2026-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022496-002	I-929	2026-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022496-001	I-929	2026-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022496-002	I-929	2026-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022496-001	I-929	2026-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022496-002	I-929	2026-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022496-001	I-929	2026-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022496-002	I-929	2026-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-001	NPP	2024-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-001	I-929	2026-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-002	NPP	2024-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022496-002	I-929	2026-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-001	NPP	2024-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-001	I-929	2026-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-002	NPP	2024-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022496-002	I-929	2026-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-001	NPP	2024-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-001	I-929	2026-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-002	NPP	2024-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022496-002	I-929	2026-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-001	NPP	2024-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-001	I-929	2026-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-002	NPP	2024-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022496-002	I-929	2026-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022496-001	NPP	2024-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022496-001	I-929	2026-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022496-002	NPP	2024-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022496-002	I-929	2026-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-001	NPP	2024-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-001	I-929	2026-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-002	NPP	2024-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022496-002	I-929	2026-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-001	NPP	2024-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-001	I-929	2026-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-002	NPP	2024-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022496-002	I-929	2026-11-09	`301d65b070ca…`

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
EXPAREL	BUPIVACAINE	Pacira Pharmaceuticals, Inc.	bb5a9e59-0f51-11df-8a39-0800200c9a66	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022496 application number: NDA022496 ndc (product): 65250-266 ndc (product): 65250-133

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals, Inc.	NDA	Current
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-133	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals, Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current
65250-266	EXPAREL	bupivacaine	Pacira Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80161	SUPPL	2024-11-05
76682	SUPPL	2023-11-29
76675	SUPPL	2023-11-29
76562	SUPPL	2023-11-14
76557	SUPPL	2023-11-13
70677	SUPPL	2022-03-31
66853	SUPPL	2021-03-24
66850	SUPPL	2021-03-24
65863	SUPPL	2021-01-07
56403	SUPPL	2018-11-09
56276	SUPPL	2018-11-05
53635	SUPPL	2018-04-06
38764	SUPPL	2015-12-14
7462	SUPPL	2015-12-14
17644	SUPPL	2014-12-16
7461	SUPPL	2014-12-09
22036	ORIG	2012-06-04
38763	ORIG	2011-11-01
7460	ORIG	2011-10-31