Home NDC 61314-143 Brimonidine Tartrate
Product NDC 61314-143
11-digit product format 613140143
Labeler code 61314
Product ID 61314-143_d30b64a2-52a4-4c29-bb4e-64cd0444127b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Sandoz Inc
Application ANDA076254
Marketing category ANDA
Marketing start 2003-09-17
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 A076254-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076254-001 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 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076254-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2003-09-16 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 61314-143-05 Brimonidine Tartrate 5 mL in 1 BOTTLE SOLUTION 5 7 61314-143-05 Brimonidine Tartrate 1 in 1 CARTON SOLUTION 1 7 61314-143-10 Brimonidine Tartrate 1 in 1 CARTON SOLUTION 1 7 61314-143-10 Brimonidine Tartrate 10 mL in 1 BOTTLE SOLUTION 10 7 61314-143-15 Brimonidine Tartrate 1 in 1 CARTON SOLUTION 1 7 61314-143-15 Brimonidine Tartrate 15 mL in 1 BOTTLE SOLUTION 15 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61314-143 BRIMONIDINE TARTRATE SOLUTION [SANDOZ INC] 6 Current NDC, Legacy NDC, 6 package rows 20220217_dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde.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 61314-143-05 61314014305 1 BOTTLE in 1 CARTON (61314-143-05) / 5 mL in 1 BOTTLE 1 bottle 2003-09-17 0000-00-00 No No Current 61314-143-10 61314014310 1 BOTTLE in 1 CARTON (61314-143-10) / 10 mL in 1 BOTTLE 1 bottle 2003-09-17 0000-00-00 No No Current 61314-143-15 61314014315 1 BOTTLE in 1 CARTON (61314-143-15) / 15 mL in 1 BOTTLE 1 bottle 2003-09-17 0000-00-00 No No Current