Home NDC 60505-0564 Brimonidine Tartrate
Product NDC 60505-0564
11-digit product format 605050564
Labeler code 60505
Product ID 60505-0564_73bc4705-71bd-5f17-71a3-b77a5b5214ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brimonidine tartrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Apotex Corp.
Application ANDA078479
Marketing category ANDA
Marketing start 2022-01-31
Substance BRIMONIDINE TARTRATE
Active strength 1.5 mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [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 44 .
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 A078479-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078479-001 AT
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 2026-10-15 13:18:30 2026-09 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078479-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2022-01-31 a50c72e98297…
Observed Orange Book normalized TE history# 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 1.5 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-0564-1 Brimonidine Tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 7 60505-0564-1 Brimonidine Tartrate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 7 60505-0564-2 Brimonidine Tartrate 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 7 60505-0564-2 Brimonidine Tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 7 60505-0564-3 Brimonidine Tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 7 60505-0564-3 Brimonidine Tartrate 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0564 BRIMONIDINE TARTRATE SOLUTION/ DROPS [APOTEX CORP.] 5 Current NDC, Legacy NDC, 6 package rows 20240921_64b21e68-610c-5194-ccb2-9d9f6ff8cda9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60505-0564-1 60505056401 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1) / 5 mL in 1 BOTTLE, DROPPER 2022-01-31 0000-00-00 No No Current 60505-0564-2 60505056402 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-2) / 10 mL in 1 BOTTLE, DROPPER 2022-03-14 0000-00-00 No No Current 60505-0564-3 60505056403 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-3) / 15 mL in 1 BOTTLE, DROPPER 2022-01-31 0000-00-00 No No Current