Home NDC 68611-190 Iluvien
Product NDC 68611-190
11-digit product format 686110190
Labeler code 68611
Product ID 68611-190_78b978f0-fc11-11f0-b558-0800200c9a66
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form IMPLANT
Route INTRAVITREAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA201923
Marketing category NDA
Marketing start 2014-10-15
Substance FLUOCINOLONE ACETONIDE
Active strength .19 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 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 N201923-001 ILUVIEN FLUOCINOLONE ACETONIDE 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N201923-001 8871241 2027-08-12 Drug product 2014-11-12 N201923-001 9849027 2028-11-07 U-4157 Drug product 2025-04-03 N201923-001 9849027 2028-11-07 U-708 Drug product 2025-04-03
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201923-001 ILUVIEN 0.19MG IMPLANT / INTRAVITREAL RLD, RS 2014-09-26 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 2 · 67 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 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201923-001 9849027 2028-11-07 U-708 Drug product 2025-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201923-001 9849027 2028-11-07 U-4157 Drug product 2025-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201923-001 9849027 2028-11-07 U-708 Drug product 2025-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201923-001 9849027 2028-11-07 U-4157 Drug product 2025-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201923-001 9849027 2028-11-07 U-708 Drug product 2025-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201923-001 9849027 2028-11-07 U-4157 Drug product 2025-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201923-001 6217895 2019-03-22 U-1597 Drug product 2014-10-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201923-001 6548078 2019-03-22 U-1597 Drug product 2014-10-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201923-001 8252307 2019-06-27 Drug product 2014-10-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201923-001 6375972 2020-04-26 U-1597 Drug product 2014-10-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201923-001 6375972 2020-04-26 U-1597 Drug product 2014-10-23 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201923-001 6375972 2020-04-26 U-1597 Drug product 2014-10-23 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N201923-001 8871241 2027-08-12 Drug product 2014-11-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201923-001 6217895 2019-03-22 U-1597 Drug product 2014-10-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201923-001 6548078 2019-03-22 U-1597 Drug product 2014-10-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201923-001 8252307 2019-06-27 Drug product 2014-10-23 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N201923-001 6375972 2020-04-26 U-1597 Drug product 2014-10-23 3f01610625f2…
Additional Listing Data#
Finished product Yes
Brand name base Iluvien
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOCINOLONE ACETONIDE .19 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 1552351 Internal RxNorm lookup 1552356 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68611-190-02 Iluvien 1 in 1 TRAY IMPLANT 1 20 68611-190-02 Iluvien 1 in 1 CARTON IMPLANT 1 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68611-190 ILUVIEN (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20250326_4400e471-7402-11df-93f2-0800200c9a66.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 Iluvien FLUOCINOLONE ACETONIDE ANI Pharmaceuticals, Inc. 4400e471-7402-11df-93f2-0800200c9a66 2026-01-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 201923 application number: NDA201923 ndc (product): 68611-190
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68611-190-02 68611019002 1 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATOR 1 tray 2014-10-15 0000-00-00 No No Current