Home NDC 60505-6225-0 Brimonidine Tartrate/Timolol Maleate
Product NDC 60505-6225
Requested package NDC 60505-6225-0
11-digit product format 605056225
Labeler code 60505
Product ID 60505-6225_27c9a4e3-a7a1-4294-8645-8f46bc529d71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brimonidine tartrate, timolol maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Apotex Corp
Application NDA021398
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-01-19
Marketing end 0000-00-00
Substance BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Active strength 2 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 N021398-001 COMBIGAN BRIMONIDINE TARTRATE; TIMOLOL MALEATE 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021398-001 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.
Product history page 1 of 2 · 41 observed 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 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC RLD, RS 2007-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021398-001 COMBIGAN 0.2%;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2007-10-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 188 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 7030149 2022-04-19 U-849 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 7320976 2022-04-19 U-849 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 7642258 2022-04-19 U-1024 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 8133890 2022-04-19 U-1235 2012-04-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 8354409 2022-04-19 U-1371 Drug product 2013-03-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 8748425 2022-04-19 U-1524 Drug product 2014-07-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 9474751 2022-04-19 U-1524 Drug product 2016-10-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 9770453 2022-04-19 U-2131 Drug product 2017-10-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 9907801 2022-04-19 U-2239 Drug product 2018-03-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021398-001 9907802 2022-04-19 U-2240 Drug product 2018-03-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021398-001 7030149 2022-04-19 U-849 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 7320976 2022-04-19 U-849 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 7642258 2022-04-19 U-1024 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 8133890 2022-04-19 U-1235 2012-04-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 8354409 2022-04-19 U-1371 Drug product 2013-03-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 8748425 2022-04-19 U-1524 Drug product 2014-07-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 9474751 2022-04-19 U-1524 Drug product 2016-10-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 9770453 2022-04-19 U-2131 Drug product 2017-10-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 9907801 2022-04-19 U-2239 Drug product 2018-03-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 9907802 2022-04-19 U-2240 Drug product 2018-03-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021398-001 7323463 2023-01-19 Drug product, Delist requested 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021398-001 7030149 2022-04-19 U-849 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 7320976 2022-04-19 U-849 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 7642258 2022-04-19 U-1024 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 8133890 2022-04-19 U-1235 2012-04-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 8354409 2022-04-19 U-1371 Drug product 2013-03-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 8748425 2022-04-19 U-1524 Drug product 2014-07-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 9474751 2022-04-19 U-1524 Drug product 2016-10-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 9770453 2022-04-19 U-2131 Drug product 2017-10-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 9907801 2022-04-19 U-2239 Drug product 2018-03-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 9907802 2022-04-19 U-2240 Drug product 2018-03-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021398-001 7323463 2023-01-19 Drug product, Delist requested 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021398-001 7030149 2022-04-19 U-849 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 7320976 2022-04-19 U-849 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 7642258 2022-04-19 U-1024 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 8133890 2022-04-19 U-1235 2012-04-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 8354409 2022-04-19 U-1371 Drug product 2013-03-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 8748425 2022-04-19 U-1524 Drug product 2014-07-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 9474751 2022-04-19 U-1524 Drug product 2016-10-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021398-001 9770453 2022-04-19 U-2131 Drug product 2017-10-12 74a2ff9319b5…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COMBIGAN BRIMONIDINE TARTRATE, TIMOLOL MALEATE Allergan, Inc. feaf1480-a4b8-4486-992a-96be3a596243 2026-03-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 021398 application number: NDA021398
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-6225-0 60505622500 1 BOTTLE, DROPPER in 1 CARTON (60505-6225-0) > 5 mL in 1 BOTTLE, DROPPER 2022-01-19 0000-00-00 No No Current