Dexycu

Product NDC: 71879-001
11-digit product format: 718790001
Labeler code: 71879
Product ID: 71879-001_44fdffcc-1f20-6598-e063-6294a90aba36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dexamethasone
Dosage form: INJECTION, SUSPENSION
Route: INTRAOCULAR
Labeler: EyePoint Pharmaceuticals US, Inc
Application: NDA208912
Marketing category: NDA
Marketing start: 2018-05-22
Substance: DEXAMETHASONE
Active strength: 517 ug/.005mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	71879-001		I	Inactivated by FDA		2026-08-11
excluded package	package	71879-001	71879-001-01	I	Inactivated by FDA		2026-08-11

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 · 16 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71879-001-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71879-001-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71879-001-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71879-001-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71879-001-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71879-001-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71879-001-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71879-001-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N208912-001	DEXYCU KIT	DEXAMETHASONE	9%	SUSPENSION / INTRAOCULAR		RLD, RS	2018-02-09

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208912-001	10799642	2032-05-11		Drug product	2021-06-11
N208912-001	10028965	2034-05-23	U-2340		2018-08-03
N208912-001	10159683	2034-05-23		Drug product	2019-01-23
N208912-001	10022502	2034-06-22	U-2340		2018-08-03
N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208912-001	DEXYCU KIT	9%	SUSPENSION / INTRAOCULAR	RLD, RS	2018-02-09	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 224 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	10799642	2032-05-11		Drug product	2021-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	10028965	2034-05-23	U-2340		2018-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	10159683	2034-05-23		Drug product	2019-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	10022502	2034-06-22	U-2340		2018-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208912-001	11097061	2039-06-23	U-3418	Drug product	2022-09-09	`5bbf6a4d5a75…`

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	N208912-001	NP	2021-02-09	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208912-001	NP	2021-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208912-001	NP	2021-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208912-001	NP	2021-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208912-001	NP	2021-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208912-001	NP	2021-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208912-001	NP	2021-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208912-001	NP	2021-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208912-001	NP	2021-02-09	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ea46721-9071-6b81-fd0a-a82bfbb014ec	Product name	7	20250220
525701df-f985-480d-995a-e0ee70c2bdf4	Product name	5	20250128
ea50b939-d92a-4100-84f5-1c1089663837	Product name	2	20240705
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
d7d46a10-8766-d3c8-ebf2-2ccd9efdcae8	Product name	2	20220506
7b2c58e8-5850-4e3e-82e9-b1593b1de761	Product name	5	20220210
81e34474-b0a5-434f-8104-25d689efc99e	Product name	1	20200303
05ab9c01-cd9a-4f59-b2e8-ddcb887cac39	Product name	1	20190408
0c7dba41-c919-5809-508d-4affe6cfcff2	Product name	2	20170817
399647c0-db89-02d1-991c-0c17b584482c	Product name	1	20140508
3e9a6377-704f-dff7-b19f-56c98d40c444	Product name	1	20140508
4d2e6ff9-14f5-b84f-c39b-373b005712c1	Product name	1	20140508
725d71bf-f956-5cad-e556-fa39cb060dc8	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71879-001-01	2025-12-02	C162847	48780-1	2cef2736-9150-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DEXYCU ® safely and effectively. See full prescribing information for DEXYCU. DEXYCU (dexamethasone intraocular suspension) 9%, for intraocular administration Initial U.S. Approval: 1958
71879-001-01	2025-01-30	C162847	48780-1	2cef2736-9150-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use DEXYCU ® safely and effectively. See full prescribing information for DEXYCU. DEXYCU (dexamethasone intraocular suspension) 9%, for intraocular administration Initial U.S. Approval: 1958

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71879-001-01	Dexycu	0.5 mL in 1 VIAL, GLASS	INJECTION, SUSPENSION	0.5		11
71879-001-01	Dexycu	1 in 1 CARTON	INJECTION, SUSPENSION	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71879-001-01	ML - Milliliter	71879-001	dca775d9-0f8c-4527-bcd7-f463fee575a6	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71879-001	DEXYCU (DEXAMETHASONE) INJECTION, SUSPENSION [EYEPOINT PHARMACEUTICALS US, INC]	10	Current NDC, Legacy NDC, 2 package rows	20230429_583d70ed-bc42-465b-983d-c770db58406f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7S5I7G3JQL	DEXAMETHASONE	50-02-2	DEXAMETHASONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2045404	dexAMETHasone 9 % in 0.005 ML Intraocular Injection	PSN	583d70ed-bc42-465b-983d-c770db58406f	11
2045409	DEXYCU 9 % in 0.005 ML Intraocular Injection	PSN	583d70ed-bc42-465b-983d-c770db58406f	11
2045409	0.005 ML dexamethasone 103.4 MG/ML Injection [Dexycu]	SBD	583d70ed-bc42-465b-983d-c770db58406f	11
2045404	0.005 ML dexamethasone 103.4 MG/ML Injection	SCD	583d70ed-bc42-465b-983d-c770db58406f	11
2045409	0.005 ML Dexycu 103.4 MG/ML Injection	SY	583d70ed-bc42-465b-983d-c770db58406f	11
2045404	dexamethasone 517 MCG per 0.005 ML Intraocular Injection	SY	583d70ed-bc42-465b-983d-c770db58406f	11
2045404	dexamethasone 9 % per 0.005 ML Intraocular Injection	SY	583d70ed-bc42-465b-983d-c770db58406f	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71879-001-01	71879000101	1 VIAL, GLASS in 1 CARTON (71879-001-01) / .5 mL in 1 VIAL, GLASS	2018-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dexycu	EyePoint Pharmaceuticals US, Inc \| Curia Massachusetts Inc \| Curia Global Inc \| Life Science Outsourcing, Inc. (LSO)	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	11