Home NDC 42571-419 Brimonidine tartrate
Product NDC 42571-419
11-digit product format 425710419
Labeler code 42571
Product ID 42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine tartrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Micro Labs Limited
Application ANDA217846
Marketing category ANDA
Marketing start 2024-04-01
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 A217846-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217846-001 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.
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 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217846-001 BRIMONIDINE TARTRATE 0.2% SOLUTION/DROPS / OPHTHALMIC AT 2023-11-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 42571-419-56 Brimonidine tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 3 42571-419-56 Brimonidine tartrate 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 3 42571-419-57 Brimonidine tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 3 42571-419-57 Brimonidine tartrate 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 3 42571-419-92 Brimonidine tartrate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 3 42571-419-92 Brimonidine tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-419 BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE) SOLUTION/ DROPS [MICRO LABS LIMITED] 2 Current NDC, 6 package rows 20240402_75c5f708-1afb-4505-94a6-a2c0afb0aedc.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 Marketing start Sample Exclude flag Status 42571-419-56 42571041956 1 BOTTLE, DROPPER in 1 CARTON (42571-419-56) / 10 mL in 1 BOTTLE, DROPPER 2024-04-01 No No Current 42571-419-57 42571041957 1 BOTTLE, DROPPER in 1 CARTON (42571-419-57) / 15 mL in 1 BOTTLE, DROPPER 2024-04-01 No No Current 42571-419-92 42571041992 1 BOTTLE, DROPPER in 1 CARTON (42571-419-92) / 5 mL in 1 BOTTLE, DROPPER 2024-04-01 No No Current