Home NDC 71565-040 Xipere
Product NDC 71565-040
11-digit product format 715650040
Labeler code 71565
Product ID 71565-040_41a36414-2553-47c7-8a9a-2bed93592e1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name triamcinolone acetonide
Dosage form INJECTION, SUSPENSION
Route OPHTHALMIC
Labeler Clearside Biomedical, Inc.
Application NDA211950
Marketing category NDA
Marketing start 2021-11-12
Marketing end 0000-00-00
Substance TRIAMCINOLONE ACETONIDE
Active strength 40 mg/mL
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N211950-001 XIPERE TRIAMCINOLONE ACETONIDE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211950-001 8636713 2027-05-02 U-3234 2021-11-04 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23
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.
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 2026-08-18 06:07:40 2026-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211950-001 XIPERE 40MG/ML SUSPENSION / INJECTION RLD, RS 2021-10-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 106 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211950-001 12419833 2040-04-16 U-3234 Drug product 2025-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 9636332 2033-11-08 U-3234 2021-11-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211950-001 9937075 2034-05-02 Drug product 2021-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211950-001 8636713 2027-05-02 U-3234 2021-11-04 301d65b070ca…
Observed Orange Book exclusivity history# 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 Xipere TRIAMCINOLONE ACETONIDE Bausch & Lomb Incorporated ea6ad429-967f-4f75-a33d-e06f849bee80 2025-10-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 211950 application number: NDA211950
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71565-040-01 71565004001 1 TRAY in 1 CARTON (71565-040-01) > 1 VIAL in 1 TRAY > .9 mL in 1 VIAL (71565-040-25) 1 tray 2021-11-12 0000-00-00 No No Current 71565-040-99 71565004099 1 TRAY in 1 CARTON (71565-040-99) > 1 VIAL in 1 TRAY > .9 mL in 1 VIAL (71565-040-95) 1 tray 2021-11-12 0000-00-00 Yes No Current