Home NDC 62332-661 Brimonidine Tartrate ophthalmic solution, 0.15%
Product NDC 62332-661
11-digit product format 623320661
Labeler code 62332
Product ID 62332-661_66c10580-37cc-4061-ac10-1474ba0e60b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brimonidine Tartrate ophthalmic solution, 0.15%
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Inc.
Application ANDA215225
Marketing category ANDA
Marketing start 2023-03-29
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215225-001 BRIMONIDINE TARTRATE BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215225-001 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 2026-08-18 06:07:40 2026-07 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215225-001 BRIMONIDINE TARTRATE 0.15% SOLUTION/DROPS / OPHTHALMIC AT 2023-03-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Brimonidine Tartrate ophthalmic solution, 0.15%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 1.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4S9CL2DY2H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861208 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 62332-661-05 Brimonidine Tartrate ophthalmic solution, 0.15% 1 in 1 CARTON SOLUTION/ DROPS 1 3 62332-661-05 Brimonidine Tartrate ophthalmic solution, 0.15% 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 3 62332-661-10 Brimonidine Tartrate ophthalmic solution, 0.15% 1 in 1 CARTON SOLUTION/ DROPS 1 3 62332-661-10 Brimonidine Tartrate ophthalmic solution, 0.15% 10 mL in 1 BOTTLE SOLUTION/ DROPS 10 3 62332-661-15 Brimonidine Tartrate ophthalmic solution, 0.15% 1 in 1 CARTON SOLUTION/ DROPS 1 3 62332-661-15 Brimonidine Tartrate ophthalmic solution, 0.15% 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-661 BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.15% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] 3 Current NDC, 6 package rows 20230405_a52b2033-0333-4630-9b1f-e22918b0962c.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 Units Marketing start Sample Exclude flag Status 62332-661-05 62332066105 1 BOTTLE in 1 CARTON (62332-661-05) / 5 mL in 1 BOTTLE 1 bottle 2023-03-29 No No Current 62332-661-10 62332066110 1 BOTTLE in 1 CARTON (62332-661-10) / 10 mL in 1 BOTTLE 1 bottle 2023-03-29 No No Current 62332-661-15 62332066115 1 BOTTLE in 1 CARTON (62332-661-15) / 15 mL in 1 BOTTLE 1 bottle 2023-03-29 No No Current