Zilretta

Product NDC: 70801-003
11-digit product format: 708010003
Labeler code: 70801
Product ID: 70801-003_2a8c0f7c-806f-4daa-8982-4e41d8ea2e63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: triamcinolone acetonide extended-release injectable suspension
Dosage form: KIT
Route: INTRA-ARTICULAR
Labeler: Flexion Therapeutics, Inc.
Application: NDA208845
Marketing category: NDA
Marketing start: 2017-10-06
Marketing end: 2023-03-31
Active strength: 0
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70801-003		D	Discontinued by firm	2026-10-05
excluded package	package	70801-003	70801-003-01	D	Discontinued by firm	2026-10-05
excluded package	package	70801-003	70801-003-02	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70801-003-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70801-003-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70801-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70801-003-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70801-003-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70801-003-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70801-003-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70801-003-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70801-003-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70801-003-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70801-003-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70801-003-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70801-003-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70801-003-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70801-003-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70801-003-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70801-003-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70801-003-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70801-003-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70801-003-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70801-003-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70801-003-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70801-003-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70801-003-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N208845-001	ZILRETTA	TRIAMCINOLONE ACETONIDE	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR		RLD, RS	2017-10-06

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
N208845-001	8828440	2031-08-04		Drug product	2017-10-31
N208845-001	9555048	2031-08-04	U-2151		2017-10-31

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208845-001	ZILRETTA	32MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	RLD, RS	2017-10-06	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 86 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	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208845-001	8828440	2031-08-04		Drug product	2017-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208845-001	9555048	2031-08-04	U-2151		2017-10-31	`74a2ff9319b5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208845-001	NP	2020-10-06	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N208845-001	NP	2020-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208845-001	NP	2020-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208845-001	NP	2020-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208845-001	NP	2020-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208845-001	NP	2020-10-06	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70801-003-01	EA - Each	70801-003	307818e5-309a-435f-8eb2-eb1a52472d60	1	2017-11-06

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
Zilretta	TRIAMCINOLONE ACETONIDE EXTENDED-RELEASE INJECTABLE SUSPENSION	Pacira Pharmaceuticals, Inc.	cd5c4673-21f2-4126-9556-da847b3a228b	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208845 application number: NDA208845

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70801-003-01	70801000301	1 KIT in 1 CARTON (70801-003-01) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (70801-001-02) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (70801-002-02) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (70801-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (70801-002-0	1 kit	2017-10-06	2023-03-31	No	No	Current
70801-003-02	70801000302	1 KIT in 1 CARTON (70801-003-02) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (70801-001-02) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (70801-002-02) * 1 INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE in 1 VIAL, SINGLE-DOSE (70801-001-01) * 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE (70801-002-0	1 kit	2017-10-06	2023-03-31	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
triamcinolone acetonide extended-release injectable suspension	Flexion Therapeutics, Inc. \| Packaging Coordinators, LLC (PCI) \| Catalent Indiana, LLC \| Synergy Health Sterilisation UK Ltd \| Patheon UK Limited \| Farmabios S.p.A. \| Alcami Carolinas Corporation	2022-12-29	HUMAN PRESCRIPTION DRUG LABEL	8