Home NDC 0832-1420 Brimonidine Tartrate
Product NDC 0832-1420
11-digit product format 008321420
Labeler code 0832
Product ID 0832-1420_4982ce05-26f4-4cbc-a7a2-77a68729044e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Upsher-Smith Laboratories, LLC
Application ANDA216772
Marketing category ANDA
Marketing start 2024-06-12
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 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 A216772-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216772-001 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 2026-09-14 22:38:34 2026-08 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2024-06-12 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216772-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC 2024-06-12 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0832-1420-05 00832142005 1 BOTTLE, DROPPER in 1 CARTON (0832-1420-05) / 5 mL in 1 BOTTLE, DROPPER 2025-11-15 No No Current 0832-1420-10 00832142010 1 BOTTLE, DROPPER in 1 CARTON (0832-1420-10) / 10 mL in 1 BOTTLE, DROPPER 2025-11-15 No No Current 0832-1420-15 00832142015 1 BOTTLE, DROPPER in 1 CARTON (0832-1420-15) / 15 mL in 1 BOTTLE, DROPPER 2025-11-15 No No Current