Brimonidine

Product NDC
17478-715
Requested package NDC
17478-715-11
11-digit product format
174780715
Labeler code
17478
Product ID
17478-715_edc8b30f-509f-44c1-b498-8cf9672aba66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brimonidine Tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA076439
Marketing category
ANDA
Marketing start
2006-09-07
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage17478-71517478-715-11IInactivated 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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
A076439-001BRIMONIDINE TARTRATEBRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076439-001AT

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 06:07:402026-07A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-143f01610625f2…
2019-09-15 20:21 UTC2019-09A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076439-001BRIMONIDINE TARTRATE0.2%SOLUTION/DROPS / OPHTHALMICAT2006-03-14e64feba35796…

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 06:07:402026-07A076439-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076439-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076439-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076439-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076439-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076439-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076439-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076439-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076439-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076439-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076439-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076439-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076439-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076439-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076439-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076439-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076439-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076439-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076439-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076439-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076439-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076439-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A076439-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076439-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076439-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076439-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A076439-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076439-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076439-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076439-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076439-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076439-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076439-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076439-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076439-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076439-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076439-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076439-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076439-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076439-001AT1e64feba35796…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-715-10Brimonidine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS59
17478-715-10Brimonidine1 in 1 CARTONSOLUTION/ DROPS19
17478-715-11Brimonidine10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109
17478-715-11Brimonidine1 in 1 CARTONSOLUTION/ DROPS19
17478-715-12Brimonidine15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS159
17478-715-12Brimonidine1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-715-10ML - Milliliter17478-715515f1cd2-c8fd-4f24-8dc1-6123182a795212012-07-24
17478-715-11ML - Milliliter17478-7159f4283b4-adb5-48e9-ab28-ec21935158ea12012-07-24
17478-715-12ML - Milliliter17478-7151eceac78-a84c-485c-b405-a96e27c5c56f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-715BRIMONIDINE (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [AKORN]9Legacy NDC, 6 package rows20220805_1ce6d79a-32c1-44dc-b50c-ada8848f39c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861200brimonidine tartrate 0.2 % Ophthalmic SolutionPSN1ce6d79a-32c1-44dc-b50c-ada8848f39c39
861200brimonidine tartrate 2 MG/ML Ophthalmic SolutionSCD1ce6d79a-32c1-44dc-b50c-ada8848f39c39
861200brimonidine tartrate 0.2 % Ophthalmic SolutionSY1ce6d79a-32c1-44dc-b50c-ada8848f39c39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-715-11174780715111 BOTTLE, DROPPER in 1 CARTON (17478-715-11) > 10 mL in 1 BOTTLE, DROPPER2006-09-070000-00-00NoNoCurrent