Retisert

Product NDC: 24208-416
11-digit product format: 242080416
Labeler code: 24208
Product ID: 24208-416_4e5bdc52-d1c0-760f-e063-6294a90a0264
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluocinolone Acetonide
Dosage form: IMPLANT
Route: INTRAVITREAL
Labeler: Bausch & Lomb Incorporated
Application: NDA021737
Marketing category: NDA
Marketing start: 2005-04-08
Substance: FLUOCINOLONE ACETONIDE
Active strength: .59 mg/1
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24208-416	24208-416-01	D	Discontinued by firm		2026-08-11

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
N021737-001	RETISERT	FLUOCINOLONE ACETONIDE	0.59MG	IMPLANT / INTRAVITREAL		RLD	2005-04-08

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	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021737-001	RETISERT	0.59MG	IMPLANT / INTRAVITREAL	RLD, RS	2005-04-08	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021737-001	6217895	2019-03-22	U-708	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021737-001	6548078	2019-03-22	U-708	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021737-001	6217895	2019-03-22	U-708	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021737-001	6548078	2019-03-22	U-708	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021737-001	6217895	2019-03-22	U-708	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021737-001	6548078	2019-03-22	U-708	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021737-001	6217895	2019-03-22	U-708	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021737-001	6548078	2019-03-22	U-708	Drug product	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Retisert
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUOCINOLONE ACETONIDE	.59 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0CD5FD6S2M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1191323	Internal RxNorm lookup
1191325	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ab0f849-2a0d-47ce-ad05-768094da8cc9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0adb2af5-1ecf-4df5-912b-16ae89228294	Product name	6	20240829
65f6255d-41cc-425f-ba54-b1bea4947886	Product name	5	20210930
5ba208e4-886f-44da-e218-ab4f4cad2c49	Product name	5	20190612
e5a2793f-318b-72fd-b734-c44ecc6f6748	Product name	2	20190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2a	Product name	1	20160622
7df2570a-c555-4d82-9189-9247c722b62c	Product name	1	20150402
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508
a78a3633-fd06-b0af-63b3-c714de3b3bfa	Product name	1	20140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24208-416-01	Retisert	1 in 1 POUCH	IMPLANT	1		16
24208-416-01	Retisert	1 in 1 CARTON	IMPLANT	1		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-416-01	EA - Each	24208-416	99d6828e-3559-4feb-bde8-8e36ea4c3f65	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOCINOLONE ACETONIDE	ACTIVE INGREDIENT	0CD5FD6S2M	RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]	7
FLUOCINOLONE ACETONIDE	ACTIVE MOIETY	0CD5FD6S2M	RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-416	RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]	15	Current NDC, Legacy NDC, 2 package rows	20250417_1ab0f849-2a0d-47ce-ad05-768094da8cc9.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
Retisert	FLUOCINOLONE ACETONIDE	Bausch & Lomb Incorporated	1ab0f849-2a0d-47ce-ad05-768094da8cc9	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021737 application number: NDA021737 ndc (product): 24208-416

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0CD5FD6S2M	FLUOCINOLONE ACETONIDE	67-73-2	FLUOCINOLONE ACETONIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1191323	fluocinolone acetonide 0.59 MG Intravitreal Drug Implant	PSN	1ab0f849-2a0d-47ce-ad05-768094da8cc9	16
1191325	Retisert 0.59 MG Intravitreal Drug Implant	PSN	1ab0f849-2a0d-47ce-ad05-768094da8cc9	16
1191325	fluocinolone acetonide 0.59 MG Drug Implant [Retisert]	SBD	1ab0f849-2a0d-47ce-ad05-768094da8cc9	16
1191323	fluocinolone acetonide 0.59 MG Drug Implant	SCD	1ab0f849-2a0d-47ce-ad05-768094da8cc9	16
1191325	Retisert 0.59 MG Drug Implant	SY	1ab0f849-2a0d-47ce-ad05-768094da8cc9	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-416-01	24208041601	1 POUCH in 1 CARTON (24208-416-01) > 1 IMPLANT in 1 POUCH	1 pouch	2005-04-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Retisert - Bausch & Lomb Incorporated \| Bausch and Lomb Ireland Limited	Bausch & Lomb Incorporated \| Bausch and Lomb Ireland Limited	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	16