Home NDC 14445-400 Brimonidine Tartrate
Product NDC 14445-400
11-digit product format 144450400
Labeler code 14445
Product ID 14445-400_383421a5-5d33-4f15-88f4-8b66fcbfac71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Indoco Remedies Limited
Application ANDA091691
Marketing category ANDA
Marketing start 2015-01-01
Substance BRIMONIDINE TARTRATE
Active strength 2 mg/mg
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 1 .
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 A091691-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091691-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091691-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2014-11-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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/mg
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 14445-400-05 Brimonidine Tartrate 05 mg in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 05 1 14445-400-10 Brimonidine Tartrate 10 mg in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 10 1 14445-400-15 Brimonidine Tartrate 15 mg in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14445-400 BRIMONIDINE TARTRATE SOLUTION/ DROPS [INDOCO REMEDIES LIMITED ] 1 Current NDC, Legacy NDC, 3 package rows 20181228_383421a5-5d33-4f15-88f4-8b66fcbfac71.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 · 2 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 14445-400-05 14445040005 5 mg in 1 BOTTLE, PLASTIC (14445-400-05) 5 mg 2015-01-01 0000-00-00 No No Current 14445-400-10 14445040010 10 mg in 1 BOTTLE, PLASTIC (14445-400-10) 10 mg 2015-01-01 0000-00-00 No No Current 14445-400-15 14445040015 15 mg in 1 BOTTLE, PLASTIC (14445-400-15) 15 mg 2015-01-01 0000-00-00 No No Current