Home NDC 73043-029 Brimonidine Tartrate and Timolol maleate Ophthalmic Solution
Product NDC 73043-029
11-digit product format 730430029
Labeler code 73043
Product ID 73043-029_aa536186-bbdf-4efa-a372-09d88070d380
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate and Timolol maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Devatis Inc.
Application ANDA217934
Marketing category ANDA
Marketing start 2026-09-15
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 A217934-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217934-001 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 A217934-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-07-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217934-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-07-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217934-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2026-07-01 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 A217934-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217934-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217934-001 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73043-029-01 73043002901 1 BOTTLE, DROPPER in 1 CARTON (73043-029-01) / 5 mL in 1 BOTTLE, DROPPER 2026-09-15 No No Current 73043-029-02 73043002902 1 BOTTLE, DROPPER in 1 CARTON (73043-029-02) / 10 mL in 1 BOTTLE, DROPPER 2026-09-15 No No Current