Home NDC 68083-664 Brimonidine Tartrate and Timolol maleate Ophthalmic Solution
Product NDC 68083-664
11-digit product format 680830664
Labeler code 68083
Product ID 68083-664_8c333ddc-18f1-4afc-8a70-1641c4f21ceb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate and Timolol maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Gland Pharma Limited
Application ANDA219166
Marketing category ANDA
Marketing start 2026-06-11
Substance BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength 2; 5 mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Antagonists [MoA], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A219166-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-06-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219166-001 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 2026-09-14 22:38:34 2026-08 A219166-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-06-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219166-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-06-11 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219166-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-06-11 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219166-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219166-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219166-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Brimonidine Tartrate and Timolol maleate Ophthalmic Solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 2 mg/mL TIMOLOL MALEATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4S9CL2DY2H Internal UNII lookup P8Y54F701R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861635 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 Marketing start Sample Exclude flag Status 68083-664-01 68083066401 1 BOTTLE, DROPPER in 1 CARTON (68083-664-01) / 15 mL in 1 BOTTLE, DROPPER 2026-06-11 No No Current