Home NDC 71879-136-01 YUTIQ
Product NDC 71879-136
Requested package NDC 71879-136-01
11-digit product format 718790136
Labeler code 71879
Product ID 71879-136_9014ab6d-e677-4993-87d3-aa9a8c250e99
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluocinolone acetonide
Dosage form IMPLANT
Route INTRAOCULAR
Labeler EyePoint Pharmaceuticals, Inc
Application NDA210331
Marketing category NDA
Marketing start 2018-10-12
Marketing end 0000-00-00
Substance FLUOCINOLONE ACETONIDE
Active strength 0 mg/1
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 71879-136 71879-136-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71879-136 71879-136-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 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 N210331-001 YUTIQ FLUOCINOLONE ACETONIDE 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12
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 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 N210331-001 7998108 2028-01-12 U-3410 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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210331-001 YUTIQ 0.18MG IMPLANT / INTRAVITREAL RLD, RS 2018-10-12 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 109 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 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N210331-001 7998108 2028-01-12 U-3410 Drug product 2022-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210331-001 6217895 2019-03-22 U-708 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 6548078 2019-03-22 U-708 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8252307 2019-06-27 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 6375972 2020-04-26 U-708 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8574613 2020-04-26 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8574659 2020-04-26 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 9192579 2020-04-26 Drug product 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 9849085 2020-04-26 U-708 2018-11-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N210331-001 8871241 2027-08-12 Drug product 2018-11-01 74a2ff9319b5…
Observed Orange Book exclusivity history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71879-136 YUTIQ (FLUOCINOLONE ACETONIDE) IMPLANT [EYEPOINT PHARMACEUTICALS, INC] 12 Legacy NDC 20250125_43ba66d9-653d-48b9-9914-b0a50b68b79a.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 YUTIQ FLUOCINOLONE ACETONIDE ANI Pharmaceuticals, Inc. f270cad8-ed82-4969-b785-831a1910bfa6 2026-02-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 210331 application number: NDA210331
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71879-136-01 71879013601 1 POUCH in 1 BOX, UNIT-DOSE (71879-136-01) > 1 APPLICATOR in 1 POUCH > 1 IMPLANT in 1 APPLICATOR 1 pouch 2018-10-12 0000-00-00 No No Current