Brimonidine Tartrate

Product NDC
50090-4224
11-digit product format
500904224
Labeler code
50090
Product ID
50090-4224_bf8ef42e-c465-4e70-ac5b-edd96463c833
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA076254
Marketing category
ANDA
Marketing start
2003-09-17
Marketing end
0000-00-00
Substance
BRIMONIDINE TARTRATE
Active strength
2 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4224IInactivated by FDA2026-08-17
excluded packagepackage50090-422450090-4224-0IInactivated by FDA2026-08-17

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 · 30 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 packagepackage50090-4224-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4224-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4224-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4224-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4224-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4224-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4224-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4224-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4224-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4224-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4224-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4224-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4224-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4224-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4224-01332a3947898…d4bfe170f9cd…

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
A076254-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076254-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-163f01610625f2…
2019-09-15 20:21 UTC2019-09A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076254-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2003-09-16e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076254-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076254-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076254-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076254-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076254-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076254-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076254-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076254-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076254-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076254-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076254-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076254-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076254-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076254-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076254-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076254-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076254-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076254-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076254-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076254-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076254-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076254-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A076254-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076254-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076254-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076254-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A076254-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076254-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076254-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076254-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076254-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076254-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076254-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076254-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076254-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076254-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076254-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076254-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076254-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076254-001AT1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4224-0Brimonidine Tartrate5 mL in 1 BOTTLESOLUTION56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4224BRIMONIDINE TARTRATE SOLUTION [A-S MEDICATION SOLUTIONS]6Legacy NDC, 1 package rows20210617_7f70f916-b4f9-4552-a002-375df20712cc.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brimonidine TartrateBRIMONIDINE TARTRATESandoz Incdfd85672-fa4b-40e3-ac9c-81b8d9e4ffde2025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076254
application number: ANDA076254

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN7f70f916-b4f9-4552-a002-375df20712cc6
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD7f70f916-b4f9-4552-a002-375df20712cc6
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY7f70f916-b4f9-4552-a002-375df20712cc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4224-0500904224005 mL in 1 BOTTLE (50090-4224-0) 5 ml2019-03-270000-00-00NoNoCurrent