Home NDC 42571-462-92 brimonidine tartrate
Product NDC 42571-462
Requested package NDC 42571-462-92
11-digit product format 425710462
Labeler code 42571
Product ID 42571-462_524ee391-fd01-9cca-e063-6294a90ac933
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brimonidine tartrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Micro Labs Limited
Application ANDA218558
Marketing category ANDA
Marketing start 2026-07-01
Substance BRIMONIDINE TARTRATE
Active strength 1 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA]; alpha-Adrenergic Agonist [EPC]
Listing certified through 2027-12-31
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 A218558-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.1% SOLUTION/DROPS / OPHTHALMIC AB 2026-05-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218558-001 AB
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218558-001 BRIMONIDINE TARTRATE 0.1% SOLUTION/DROPS / OPHTHALMIC AB 2026-05-07 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218558-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base brimonidine tartrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 1 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 861204 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 42571-462-92 42571046292 1 BOTTLE in 1 CARTON (42571-462-92) / 5 mL in 1 BOTTLE 1 bottle 2026-07-01 0 Current