Application 211988

Type: NDA
Sponsor: Heron Therapeutics, Inc.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	Zynrelef	bupivacaine and meloxicam	SOLUTION;INJECTION	60MG/1.8MG	No	No
002	Zynrelef	bupivacaine and meloxicam	SOLUTION; INJECTION	200MG/6MG	No	No
003	Zynrelef	bupivacaine and meloxicam	SOLUTION; INJECTION	300MG/9MG	No	No
004	Zynrelef	bupivacaine and meloxicam	SOLUTION; INJECTION	400MG/12MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211988-001	ZYNRELEF KIT	BUPIVACAINE; MELOXICAM	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12
N211988-002	ZYNRELEF KIT	BUPIVACAINE; MELOXICAM	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12
N211988-003	ZYNRELEF KIT	BUPIVACAINE; MELOXICAM	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12
N211988-004	ZYNRELEF KIT	BUPIVACAINE; MELOXICAM	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12

Orange Book patents#

Current patent rows page 1 of 1 · 64 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211988-001	10398686	2034-03-13		Drug product	2021-05-26
N211988-001	11253504	2034-03-13	U-3118		2022-03-02
N211988-001	9592227	2034-03-13	U-3118	Drug product	2021-05-26
N211988-001	9744163	2034-03-13		Drug product	2021-05-26
N211988-001	9913909	2034-03-13	U-3118		2021-05-26
N211988-001	10098957	2035-04-20	U-3118		2021-05-26
N211988-001	10213510	2035-04-20	U-3118	Drug product	2021-05-26
N211988-001	10632199	2035-04-20	U-3118	Drug product	2021-05-26
N211988-001	10898575	2035-04-20	U-3118	Drug product	2021-05-26
N211988-001	10980886	2035-04-20		Drug product	2021-05-26
N211988-001	11083730	2035-04-20	U-3118	Drug product	2021-08-25
N211988-001	11083797	2035-04-20	U-3118	Drug product	2021-08-25
N211988-001	11413350	2035-04-20	U-3417		2022-09-15
N211988-001	9694079	2035-04-20	U-3118	Drug product	2021-05-26
N211988-001	9801945	2035-04-20	U-3118	Drug product	2021-05-26
N211988-001	11844837	2036-04-21	U-3417		2024-01-03
N211988-002	10398686	2034-03-13		Drug product	2021-05-26
N211988-002	11253504	2034-03-13	U-3118		2022-03-02
N211988-002	9592227	2034-03-13	U-3118	Drug product	2021-05-26
N211988-002	9744163	2034-03-13		Drug product	2021-05-26
N211988-002	9913909	2034-03-13	U-3118		2021-05-26
N211988-002	10098957	2035-04-20	U-3118		2021-05-26
N211988-002	10213510	2035-04-20	U-3118	Drug product	2021-05-26
N211988-002	10632199	2035-04-20	U-3118	Drug product	2021-05-26
N211988-002	10898575	2035-04-20	U-3118	Drug product	2021-05-26
N211988-002	10980886	2035-04-20		Drug product	2021-05-26
N211988-002	11083730	2035-04-20	U-3118	Drug product	2021-08-25
N211988-002	11083797	2035-04-20	U-3118	Drug product	2021-08-25
N211988-002	11413350	2035-04-20	U-3417		2022-09-15
N211988-002	9694079	2035-04-20	U-3118	Drug product	2021-05-26
N211988-002	9801945	2035-04-20	U-3118	Drug product	2021-05-26
N211988-002	11844837	2036-04-21	U-3417		2024-01-03
N211988-003	10398686	2034-03-13		Drug product	2021-05-26
N211988-003	11253504	2034-03-13	U-3118		2022-03-02
N211988-003	9592227	2034-03-13	U-3118	Drug product	2021-05-26
N211988-003	9744163	2034-03-13		Drug product	2021-05-26
N211988-003	9913909	2034-03-13	U-3118		2021-05-26
N211988-003	10098957	2035-04-20	U-3118		2021-05-26
N211988-003	10213510	2035-04-20	U-3118	Drug product	2021-05-26
N211988-003	10632199	2035-04-20	U-3118	Drug product	2021-05-26
N211988-003	10898575	2035-04-20	U-3118	Drug product	2021-05-26
N211988-003	10980886	2035-04-20		Drug product	2021-05-26
N211988-003	11083730	2035-04-20	U-3118	Drug product	2021-08-25
N211988-003	11083797	2035-04-20	U-3118	Drug product	2021-08-25
N211988-003	11413350	2035-04-20	U-3417		2022-09-15
N211988-003	9694079	2035-04-20	U-3118	Drug product	2021-05-26
N211988-003	9801945	2035-04-20	U-3118	Drug product	2021-05-26
N211988-003	11844837	2036-04-21	U-3417		2024-01-03
N211988-004	10398686	2034-03-13		Drug product	2021-05-26
N211988-004	11253504	2034-03-13	U-3118		2022-03-02
N211988-004	9592227	2034-03-13	U-3118	Drug product	2021-05-26
N211988-004	9744163	2034-03-13		Drug product	2021-05-26
N211988-004	9913909	2034-03-13	U-3118		2021-05-26
N211988-004	10098957	2035-04-20	U-3118		2021-05-26
N211988-004	10213510	2035-04-20	U-3118	Drug product	2021-05-26
N211988-004	10632199	2035-04-20	U-3118	Drug product	2021-05-26
N211988-004	10898575	2035-04-20	U-3118	Drug product	2021-05-26
N211988-004	10980886	2035-04-20		Drug product	2021-05-26
N211988-004	11083730	2035-04-20	U-3118	Drug product	2021-08-25
N211988-004	11083797	2035-04-20	U-3118	Drug product	2021-08-25
N211988-004	11413350	2035-04-20	U-3417		2022-09-15
N211988-004	9694079	2035-04-20	U-3118	Drug product	2021-05-26
N211988-004	9801945	2035-04-20	U-3118	Drug product	2021-05-26
N211988-004	11844837	2036-04-21	U-3417		2024-01-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211988-001	I-933	2027-01-23
N211988-002	I-933	2027-01-23
N211988-003	I-933	2027-01-23
N211988-004	I-933	2027-01-23

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 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211988-001	ZYNRELEF KIT	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211988-002	ZYNRELEF KIT	200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211988-003	ZYNRELEF KIT	300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD	2021-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211988-004	ZYNRELEF KIT	400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	SOLUTION, EXTENDED RELEASE / PERIARTICULAR	RLD, RS	2021-05-12	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 52 · 2,076 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	N211988-001	10398686	2034-03-13		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	11253504	2034-03-13	U-3118		2022-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	9592227	2034-03-13	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	9744163	2034-03-13		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	9913909	2034-03-13	U-3118		2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	10098957	2035-04-20	U-3118		2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	10213510	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	10632199	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	10898575	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	10980886	2035-04-20		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	11083730	2035-04-20	U-3118	Drug product	2021-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	11083797	2035-04-20	U-3118	Drug product	2021-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	11413350	2035-04-20	U-3417		2022-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	9694079	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	9801945	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-001	11844837	2036-04-21	U-3417		2024-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	10398686	2034-03-13		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	11253504	2034-03-13	U-3118		2022-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	9592227	2034-03-13	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	9744163	2034-03-13		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	9913909	2034-03-13	U-3118		2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	10098957	2035-04-20	U-3118		2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	10213510	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	10632199	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	10898575	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	10980886	2035-04-20		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	11083730	2035-04-20	U-3118	Drug product	2021-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	11083797	2035-04-20	U-3118	Drug product	2021-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	11413350	2035-04-20	U-3417		2022-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	9694079	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	9801945	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	11844837	2036-04-21	U-3417		2024-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	10398686	2034-03-13		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	11253504	2034-03-13	U-3118		2022-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	9592227	2034-03-13	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	9744163	2034-03-13		Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	9913909	2034-03-13	U-3118		2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	10098957	2035-04-20	U-3118		2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	10213510	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	10632199	2035-04-20	U-3118	Drug product	2021-05-26	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 172 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	N211988-001	I-933	2027-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-002	I-933	2027-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-003	I-933	2027-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211988-004	I-933	2027-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211988-001	I-933	2027-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211988-002	I-933	2027-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211988-003	I-933	2027-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211988-004	I-933	2027-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-001	I-933	2027-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-002	I-933	2027-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-003	I-933	2027-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211988-004	I-933	2027-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211988-001	I-933	2027-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211988-002	I-933	2027-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211988-003	I-933	2027-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211988-004	I-933	2027-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-001	I-933	2027-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-002	I-933	2027-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-003	I-933	2027-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211988-004	I-933	2027-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-001	I-933	2027-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-002	I-933	2027-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-003	I-933	2027-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211988-004	I-933	2027-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-001	NP	2024-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-001	I-933	2027-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-002	NP	2024-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-002	I-933	2027-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-003	NP	2024-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-003	I-933	2027-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-004	NP	2024-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211988-004	I-933	2027-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-001	NP	2024-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-001	I-933	2027-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-002	NP	2024-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-002	I-933	2027-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-003	NP	2024-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-003	I-933	2027-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-004	NP	2024-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211988-004	I-933	2027-01-23	`2680178bc6a6…`

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
ZYNRELEF	BUPIVACAINE AND MELOXICAM	Heron Therapeutics, Inc.	dab484a7-9353-43ba-9e74-7fab910c712b	2026-04-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211988 application number: NDA211988 ndc (product): 47426-301 ndc (product): 47426-303 ndc (product): 47426-304 ndc (product): 47426-302

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47426-301	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-301	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-301	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-302	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-302	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-302	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-303	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-303	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-303	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-304	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-304	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current
47426-304	ZYNRELEF	BUPIVACAINE and MELOXICAM	Heron Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85651	SUPPL	2026-04-07
85650	SUPPL	2026-04-07
80401	SUPPL	2024-11-25
80318	SUPPL	2024-11-22
77885	SUPPL	2024-03-21
77297	SUPPL	2024-01-25
77284	SUPPL	2024-01-24
71469	SUPPL	2022-06-28
70687	ORIG	2022-04-05
69526	SUPPL	2021-12-10
69520	SUPPL	2021-12-09
67484	ORIG	2021-05-13
67481	ORIG	2021-05-13