Home NDC 65145-163 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Product NDC 65145-163
11-digit product format 651450163
Labeler code 65145
Product ID 65145-163_eac3cec2-b373-4936-89f0-c6d300e09f6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate and Timolol Maleate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Caplin Steriles Limited
Application ANDA219093
Marketing category ANDA
Marketing start 2025-03-10
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 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 A219093-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2025-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219093-001 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 2026-02-19 14:30 UTC 2026-02 A219093-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2025-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219093-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2025-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219093-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2025-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219093-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2025-02-25 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219093-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2025-02-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Listing expiration 2026-12-31 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 P8Y54F701R Internal UNII lookup 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 861635 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 65145-163-01 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 1 in 1 CARTON SOLUTION 1 1 65145-163-01 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 10 mL in 1 BOTTLE, DROPPER SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65145-163 BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE) SOLUTION [CAPLIN STERILES LIMITED] 1 Current NDC, 2 package rows 20250311_eac3cec2-b373-4936-89f0-c6d300e09f6e.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 Marketing start Sample Exclude flag Status 65145-163-01 65145016301 1 BOTTLE, DROPPER in 1 CARTON (65145-163-01) / 10 mL in 1 BOTTLE, DROPPER 2025-03-10 No No Current