Home NDC 46708-706 Brimonidine Tartrate and Timolol Maleate
Product NDC 46708-706
11-digit product format 467080706
Labeler code 46708
Product ID 46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate and Timolol Maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Limited
Application ANDA215230
Marketing category ANDA
Marketing start 2023-08-25
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 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215230-001 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 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215230-001 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB 2023-08-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Brimonidine Tartrate and Timolol Maleate
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-706-05 Brimonidine Tartrate and Timolol Maleate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 1 46708-706-05 Brimonidine Tartrate and Timolol Maleate 1 in 1 CARTON SOLUTION/ DROPS 1 1 46708-706-10 Brimonidine Tartrate and Timolol Maleate 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 1 46708-706-10 Brimonidine Tartrate and Timolol Maleate 1 in 1 CARTON SOLUTION/ DROPS 1 1 46708-706-15 Brimonidine Tartrate and Timolol Maleate 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 1 46708-706-15 Brimonidine Tartrate and Timolol Maleate 1 in 1 CARTON SOLUTION/ DROPS 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-706 BRIMONIDINE TARTRATE AND TIMOLOL MALEATE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 6 package rows 20230901_b5d560b6-847e-4f09-b1ef-22e4deb8a206.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 46708-706-05 46708070605 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPER 2023-08-25 No No Current 46708-706-10 46708070610 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPER 2023-08-25 No No Current 46708-706-15 46708070615 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPER 2023-08-25 No No Current