EXPAREL

Product NDC: 65250-266
11-digit product format: 652500266
Labeler code: 65250
Product ID: 65250-266_7dd52279-ea2e-4f8c-8e29-8172bc3ed882
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupivacaine
Dosage form: INJECTION, SUSPENSION, LIPOSOMAL
Route: INFILTRATION
Labeler: Pacira Pharmaceuticals, Inc.
Application: NDA022496
Marketing category: NDA
Marketing start: 2012-01-01
Substance: BUPIVACAINE
Active strength: 13.3 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
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 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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BUPIVACAINE	13.3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y8335394RO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191508	Internal RxNorm lookup
1191513	Internal RxNorm lookup
1745061	Internal RxNorm lookup
1745062	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
bb5a9e59-0f51-11df-8a39-0800200c9a66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cbf85893-59ef-423f-87d4-a573c000a8b9	Product name	8	20250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435	Product name	2	20250303
e3a99641-4540-4894-9108-00cab3c57b7e	Product name	1	20211207
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65250-266-04	EXPAREL	4 in 1 CARTON	INJECTION, SUSPENSION, LIPOSOMAL	4	32
65250-266-09	EXPAREL	10 in 1 CARTON	INJECTION, SUSPENSION, LIPOSOMAL	10	32
65250-266-20	EXPAREL	20 mL in 1 VIAL	INJECTION, SUSPENSION, LIPOSOMAL	20	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65250-266-04	ML - Milliliter	65250-266	ec46846f-9944-4e6d-a959-dd45f0ab03ab	1	2017-04-05
65250-266-09	ML - Milliliter	65250-266	4af6a36d-5755-4bf5-a7b6-4c1e69c2514c	1	2017-03-06
65250-266-20	ML - Milliliter	65250-266	d9fc2b4c-b59b-4707-8e69-dc8e5f11ce45	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BUPIVACAINE	ACTIVE INGREDIENT	Y8335394RO	EXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS INC.]	6
BUPIVACAINE	ACTIVE MOIETY	Y8335394RO	EXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65250-266	EXPAREL (BUPIVACAINE) INJECTION, SUSPENSION, LIPOSOMAL [PACIRA PHARMACEUTICALS, INC.]	31	Current NDC, Legacy NDC, 3 package rows	20241218_bb5a9e59-0f51-11df-8a39-0800200c9a66.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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y8335394RO	BUPIVACAINE	38396-39-3	BUPIVACAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1745061	BUPivacaine liposome 1.3 % in 10 ML Injection	PSN	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191508	BUPivacaine liposome 1.3 % in 20 ML Injection	PSN	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1745062	EXPAREL 1.3 % in 10 ML Injection	PSN	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191513	EXPAREL 1.3 % in 20 ML Injection	PSN	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1745062	10 ML bupivacaine liposome 13.3 MG/ML Injection [Exparel]	SBD	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191513	20 ML bupivacaine liposome 13.3 MG/ML Injection [Exparel]	SBD	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1745061	10 ML bupivacaine liposome 13.3 MG/ML Injection	SCD	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191508	20 ML bupivacaine liposome 13.3 MG/ML Injection	SCD	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1745062	10 ML Exparel 13.3 MG/ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191513	20 ML Exparel 13.3 MG/ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191508	bupivacaine liposome 1.3 % in 20 ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1745061	bupivacaine liposome 133 MG per 10 ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191508	bupivacaine liposome 266 MG per 20 ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191513	Exparel 1.3 % in 20 ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1745062	Exparel 133 MG per 10 ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32
1191513	Exparel 266 MG per 20 ML Injection	SY	bb5a9e59-0f51-11df-8a39-0800200c9a66	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65250-266-04	65250026604	4 VIAL in 1 CARTON (65250-266-04) / 20 mL in 1 VIAL (65250-266-20)	4 vial	2016-09-28	0000-00-00	No	No	Current
65250-266-09	65250026609	10 VIAL in 1 CARTON (65250-266-09) / 20 mL in 1 VIAL (65250-266-20)	10 vial	2017-03-31	0000-00-00	No	No	Current
65250-266-20	65250026620	20 mL in 1 VIAL	20 ml					Historical