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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71565-040DDiscontinued by firm2026-08-17
excluded packagepackage71565-04071565-040-01DDiscontinued by firm2026-08-17
excluded packagepackage71565-04071565-040-99DDiscontinued by firm2026-08-17

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71565-040-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71565-040-99d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71565-040-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71565-040-99f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71565-040-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71565-040-992ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71565-040-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71565-040-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71565-040-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71565-040-99cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71565-040-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71565-040-99cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71565-040-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71565-040-99302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71565-040-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71565-040-99ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71565-040-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71565-040-990efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211950-001XIPERETRIAMCINOLONE ACETONIDE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211950-00186367132027-05-02U-32342021-11-04
N211950-00196363322033-11-08U-32342021-11-04
N211950-00199370752034-05-02Drug product2021-11-04
N211950-001124198332040-04-16U-3234Drug product2025-10-23

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211950-001XIPERE40MG/MLSUSPENSION / INJECTIONRLD, RS2021-10-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N211950-00186367132027-05-02U-32342021-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N211950-00196363322033-11-08U-32342021-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N211950-00199370752034-05-02Drug product2021-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N211950-001124198332040-04-16U-3234Drug product2025-10-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211950-00186367132027-05-02U-32342021-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211950-00196363322033-11-08U-32342021-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211950-00199370752034-05-02Drug product2021-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211950-001124198332040-04-16U-3234Drug product2025-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211950-00186367132027-05-02U-32342021-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211950-00196363322033-11-08U-32342021-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211950-00199370752034-05-02Drug product2021-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211950-001124198332040-04-16U-3234Drug product2025-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N211950-00186367132027-05-02U-32342021-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211950-00196363322033-11-08U-32342021-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211950-00199370752034-05-02Drug product2021-11-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211950-00186367132027-05-02U-32342021-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211950-00196363322033-11-08U-32342021-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211950-00199370752034-05-02Drug product2021-11-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211950-00186367132027-05-02U-32342021-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211950-00196363322033-11-08U-32342021-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211950-00199370752034-05-02Drug product2021-11-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211950-00186367132027-05-02U-32342021-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211950-00196363322033-11-08U-32342021-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211950-00199370752034-05-02Drug product2021-11-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211950-00186367132027-05-02U-32342021-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211950-00196363322033-11-08U-32342021-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211950-00199370752034-05-02Drug product2021-11-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211950-00186367132027-05-02U-32342021-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211950-00196363322033-11-08U-32342021-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211950-00199370752034-05-02Drug product2021-11-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211950-00186367132027-05-02U-32342021-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211950-00196363322033-11-08U-32342021-11-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211950-00199370752034-05-02Drug product2021-11-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211950-00186367132027-05-02U-32342021-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N211950-00196363322033-11-08U-32342021-11-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N211950-00199370752034-05-02Drug product2021-11-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211950-00186367132027-05-02U-32342021-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211950-00196363322033-11-08U-32342021-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211950-00199370752034-05-02Drug product2021-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211950-00186367132027-05-02U-32342021-11-04301d65b070ca…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N211950-001NP2024-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N211950-001NP2024-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N211950-001NP2024-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N211950-001NP2024-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N211950-001NP2024-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N211950-001NP2024-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N211950-001NP2024-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N211950-001NP2024-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N211950-001NP2024-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N211950-001NP2024-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N211950-001NP2024-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N211950-001NP2024-10-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N211950-001NP2024-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N211950-001NP2024-10-22782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N211950-001NP2024-10-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N211950-001NP2024-10-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N211950-001NP2024-10-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N211950-001NP2024-10-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N211950-001NP2024-10-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N211950-001NP2024-10-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N211950-001NP2024-10-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N211950-001NP2024-10-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N211950-001NP2024-10-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N211950-001NP2024-10-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N211950-001NP2024-10-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N211950-001NP2024-10-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N211950-001NP2024-10-22cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71565-040-01ML - Milliliter71565-040f9404019-e362-42b2-b875-7e5e4fbd05e512021-12-08
71565-040-25ML - Milliliter71565-040e299154f-5ac6-4cd9-b099-a477e9a61c7f12021-12-08

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XipereTRIAMCINOLONE ACETONIDEBausch & Lomb Incorporatedea6ad429-967f-4f75-a33d-e06f849bee802025-10-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 211950
application number: NDA211950

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71565-040-01715650040011 TRAY in 1 CARTON (71565-040-01) > 1 VIAL in 1 TRAY > .9 mL in 1 VIAL (71565-040-25) 1 tray2021-11-120000-00-00NoNoCurrent
71565-040-99715650040991 TRAY in 1 CARTON (71565-040-99) > 1 VIAL in 1 TRAY > .9 mL in 1 VIAL (71565-040-95) 1 tray2021-11-120000-00-00YesNoCurrent