Home NDC 70069-231 BRIMONIDINE TARTRATE
Product NDC 70069-231
11-digit product format 700690231
Labeler code 70069
Product ID 70069-231_fd76c55c-cb68-4884-8a1a-a4c6bf66562a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BRIMONIDINE TARTRATE
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Somerset Therapeutics, LLC
Application ANDA208992
Marketing category ANDA
Marketing start 2019-03-11
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 2026-12-31
Current FDA listing Yes 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 A208992-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208992-001 AT
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 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 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208992-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2019-03-11 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base BRIMONIDINE TARTRATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4S9CL2DY2H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861200 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70069-231-01 BRIMONIDINE TARTRATE 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 10 70069-231-01 BRIMONIDINE TARTRATE 1 in 1 CARTON SOLUTION/ DROPS 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-231 BRIMONIDINE TARTRATE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250326_cdb8620f-adfa-4433-b285-9c42334f8600.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70069-231-01 70069023101 1 BOTTLE in 1 CARTON (70069-231-01) / 5 mL in 1 BOTTLE 1 bottle 2019-03-11 0000-00-00 No No Current