Application 204803

Type: NDA
Sponsor: DURECT CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POSIMIR	BUPIVACAINE	INJECTABLE;INJECTION	132MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204803-001	POSIMIR	BUPIVACAINE	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION		RLD	2021-02-01

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204803-001	11400019	2041-01-12		Drug product	2022-09-01
N204803-001	11771624	2041-01-12	U-3724		2023-11-02

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD, RS	2021-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD, RS	2021-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD, RS	2021-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD	2021-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD	2021-02-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD	2021-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD	2021-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD	2021-02-01	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION, EXTENDED RELEASE / INFILTRATION	RLD, RS	2021-02-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204803-001	POSIMIR	660MG/5ML (132MG/ML)	SOLUTION / INFILTRATION	RLD	2021-02-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 178 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	8153149	2025-09-15		Drug product	2021-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	8153661	2025-09-15	U-3074		2021-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	8753665	2025-09-15	U-3074	Drug product	2021-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	8846072	2025-09-15	U-3074	Drug product	2021-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204803-001	8153149	2025-09-15		Drug product	2021-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204803-001	8153661	2025-09-15	U-3074		2021-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204803-001	8753665	2025-09-15	U-3074	Drug product	2021-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204803-001	8846072	2025-09-15	U-3074	Drug product	2021-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	8153149	2025-09-15		Drug product	2021-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	8153661	2025-09-15	U-3074		2021-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	8753665	2025-09-15	U-3074	Drug product	2021-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	8846072	2025-09-15	U-3074	Drug product	2021-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	8153149	2025-09-15		Drug product	2021-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	8153661	2025-09-15	U-3074		2021-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	8753665	2025-09-15	U-3074	Drug product	2021-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	8846072	2025-09-15	U-3074	Drug product	2021-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	8153149	2025-09-15		Drug product	2021-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	8153661	2025-09-15	U-3074		2021-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	8753665	2025-09-15	U-3074	Drug product	2021-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	8846072	2025-09-15	U-3074	Drug product	2021-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	11400019	2041-01-12		Drug product	2022-09-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	11771624	2041-01-12	U-3724		2023-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204803-001	8153149	2025-09-15		Drug product	2021-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204803-001	8153661	2025-09-15	U-3074		2021-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204803-001	8753665	2025-09-15	U-3074	Drug product	2021-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204803-001	8846072	2025-09-15	U-3074	Drug product	2021-03-02	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204803-001	NP	2024-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204803-001	NP	2024-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204803-001	NP	2024-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204803-001	NP	2024-02-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204803-001	NP	2024-02-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204803-001	NP	2024-02-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204803-001	NP	2024-02-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204803-001	NP	2024-02-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204803-001	NP	2024-02-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204803-001	NP	2024-02-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204803-001	NP	2024-02-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204803-001	NP	2024-02-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204803-001	NP	2024-02-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204803-001	NP	2024-02-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204803-001	NP	2024-02-01	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204803-001	NP	2024-02-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204803-001	NP	2024-02-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204803-001	NP	2024-02-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204803-001	NP	2024-02-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204803-001	NP	2024-02-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204803-001	NP	2024-02-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204803-001	NP	2024-02-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204803-001	NP	2024-02-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204803-001	NP	2024-02-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204803-001	NP	2024-02-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204803-001	NP	2024-02-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204803-001	NP	2024-02-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204803-001	NP	2024-02-01	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXPAREL	BUPIVACAINE	Pacira Pharmaceuticals, Inc.	bb5a9e59-0f51-11df-8a39-0800200c9a66	2025-12-12	Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE
Bupivacaine	BUPIVACAINE	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	0af296bb-1599-4b35-b66b-994924d3e898	2024-07-09	Warnings, Adverse reactions	Name fallback generic name: BUPIVACAINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49396-6601	POSIMIR	Bupivacaine	Renaissance Lakewood, LLC	NDA	Current
51715-660	POSIMIR	bupivacaine	INNOCOLL PHARMACEUTICALS	NDA	Current
51715-660	POSIMIR	bupivacaine	INNOCOLL PHARMACEUTICALS	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71731	SUPPL	2022-08-05
71720	SUPPL	2022-08-04
71163	ORIG	2022-05-31
66072	ORIG	2021-02-03
66054	ORIG	2021-02-02