ZYNRELEF

Product NDC: 47426-301
11-digit product format: 474260301
Labeler code: 47426
Product ID: 47426-301_c89236a8-214c-4de1-b60c-9284efeabe58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUPIVACAINE and MELOXICAM
Dosage form: SOLUTION
Route: INFILTRATION
Labeler: Heron Therapeutics, Inc.
Application: NDA211988
Marketing category: NDA
Marketing start: 2021-07-01
Marketing end: 0000-00-00
Substance: BUPIVACAINE; MELOXICAM
Active strength: 400 mg/14mL; mg/14mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	47426-301		D	Discontinued by firm		2026-08-17
excluded package	package	47426-301	47426-301-02	D	Discontinued by firm		2026-08-17

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bdef11ce-16e2-4690-96a3-597bcf5cc738	Product name	1	20260130
f2791553-0b76-42f4-8d49-af3eda072bfb	Product name	1	20251117
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
3e9b4ed6-844c-4725-9d19-cceb5c823572	Product name	2	20210903
5da98533-f072-406b-9e1b-6ac19eca9926	Product name	1	20210622
306b993e-3140-4823-ad5e-88b708f9d2ac	Product name	1	20210510
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7	Product name	1	20200623
a831e694-3663-4a83-82be-6c309429f750	Product name	2	20200608
a428d1db-64d7-4fc3-8d13-832b1e84b683	Product name	1	20190201
96649a58-aac8-401c-be00-450b4335f7e7	Product name	1	20161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1	Product name	2	20161116

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47426-301-02	2024-09-18	C162847	48780-1	1e7a6dab-1ec9-a2ce-e063-dadaa90aadf7	These highlights do not include all the information needed to use ZYNRELEF ® safely and effectively. See full prescribing information for ZYNRELEF. ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for instillation use Initial U.S. Approval: 2021
47426-301-02	2024-07-30	C162847	48780-1	1e7a6dab-1ec9-a2ce-e063-dadaa90aadf7	These highlights do not include all the information needed to use ZYNRELEF ® safely and effectively. See full prescribing information for ZYNRELEF. ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for instillation use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
47426-301-02	ZYNRELEF	1 in 1 KIT	SOLUTION	1	16
47426-301-04	ZYNRELEF	1 in 1 CARTON	SOLUTION	1	16
47426-301-06	ZYNRELEF	14 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	14	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47426-301-02	ML - Milliliter	47426-301	21902a12-b0dc-42ed-8875-b27d1b2a7189	1	2021-07-15
47426-301-06	ML - Milliliter	47426-301	de149819-b34f-4a60-8c7b-91fd546ac6e7	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47426-301	ZYNRELEF (BUPIVACAINE AND MELOXICAM) SOLUTION [HERON THERAPEUTICS, INC.]	13	Legacy NDC, 3 package rows	20241206_dab484a7-9353-43ba-9e74-7fab910c712b.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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y8335394RO	BUPIVACAINE	38396-39-3	BUPIVACAINE
VG2QF83CGL	MELOXICAM	71125-38-7	MELOXICAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2560321	BUPivacaine 200 MG / meloxicam 6 MG in 7 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560315	BUPivacaine 300 MG / meloxicam 9 MG in 10.5 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560312	BUPivacaine 400 MG / meloxicam 12 MG in 14 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560319	BUPivacaine 60 MG / meloxicam 1.8 MG in 2.3 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560306	ZYNRELEF (BUPivacaine 200 MG / meloxicam 6 MG) in 7 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560309	ZYNRELEF (BUPivacaine 300 MG / meloxicam 9 MG) in 10.5 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560308	ZYNRELEF (BUPivacaine 400 MG / meloxicam 12 MG) in 14 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560311	ZYNRELEF (BUPivacaine 60 MG / meloxicam 1.8 MG) in 2.3 ML Extended Release Solution	PSN	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560309	10.5 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]	SBD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560308	14 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]	SBD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560311	2.3 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]	SBD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560306	7 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]	SBD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560315	10.5 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection	SCD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560312	14 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection	SCD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560319	2.3 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection	SCD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560321	7 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection	SCD	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560321	bupivacaine 200 MG / meloxicam 6 MG per 7 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560315	bupivacaine 300 MG / meloxicam 9 MG per 10.5 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560312	bupivacaine 400 MG / meloxicam 12 MG per 14 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560319	bupivacaine 60 MG / meloxicam 1.8 MG per 2.3 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560306	Zynrelef (bupivacaine 200 MG / meloxicam 6 MG) per 7 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560309	Zynrelef (bupivacaine 300 MG / meloxicam 9 MG) per 10.5 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560308	Zynrelef (bupivacaine 400 MG / meloxicam 12 MG) per 14 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16
2560311	Zynrelef (bupivacaine 60 MG / meloxicam 1.8 MG) per 2.3 ML Extended Release Solution	SY	dab484a7-9353-43ba-9e74-7fab910c712b	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47426-301-02	47426030102	1 CARTON in 1 KIT (47426-301-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 14 mL in 1 VIAL, SINGLE-DOSE	1 carton	2021-07-01	0000-00-00	No	No	Current
47426-301-04	47426030104	1 in 1 CARTON						Historical
47426-301-06	47426030106	14 mL in 1 VIAL, SINGLE-DOSE	14 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZYNRELEF	Heron Therapeutics, Inc. \| Lifecore Biomedical \| Apitoria Pharma, Ltd. \| Cambrex Karlskoga AB \| Pharma Packaging Solutions	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	16