Home NDC 82182-321 Brimonidine tartrate
Product NDC 82182-321
11-digit product format 821820321
Labeler code 82182
Product ID 82182-321_63e74b48-0ee2-40e8-a81f-008103768e17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brimonidine tartrate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Pacific Pharma, Inc.
Application NDA021770
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-01-02
Substance BRIMONIDINE TARTRATE
Active strength 1 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 N021770-001 ALPHAGAN P BRIMONIDINE TARTRATE 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021770-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 6 · 230 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021770-001 8858961*PED 2024-03-02 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021770-001 8858961*PED 2024-03-02 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021770-001 8858961*PED 2024-03-02 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021770-001 8858961*PED 2024-03-02 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021770-001 8858961*PED 2024-03-02 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021770-001 8858961*PED 2024-03-02 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021770-001 8858961*PED 2024-03-02 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021770-001 8858961*PED 2024-03-02 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021770-001 8858961*PED 2024-03-02 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 6562873*PED 2022-01-10 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 9295641*PED 2022-01-10 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 9687443*PED 2022-01-10 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 6627210*PED 2022-01-18 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 6673337*PED 2022-01-26 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 6641834*PED 2022-01-28 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 8858961 2023-09-02 Drug product 2014-11-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021770-001 8858961*PED 2024-03-02 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021770-001 6562873*PED 2022-01-10 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 9295641*PED 2022-01-10 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 9687443*PED 2022-01-10 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 6627210*PED 2022-01-18 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 6673337*PED 2022-01-26 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 6641834*PED 2022-01-28 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 8858961 2023-09-02 Drug product 2014-11-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021770-001 8858961*PED 2024-03-02 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021770-001 6562873*PED 2022-01-10 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 9295641*PED 2022-01-10 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 9687443*PED 2022-01-10 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 6627210*PED 2022-01-18 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 6673337*PED 2022-01-26 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 6641834*PED 2022-01-28 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 8858961 2023-09-02 Drug product 2014-11-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021770-001 8858961*PED 2024-03-02 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021770-001 10307368 2021-07-10 Drug product 2019-06-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021770-001 6562873 2021-07-10 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021770-001 9295641 2021-07-10 U-1833 2016-04-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021770-001 9687443 2021-07-10 Drug product 2017-07-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021770-001 6627210 2021-07-18 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021770-001 6673337 2021-07-26 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021770-001 6641834 2021-07-28 Drug product 74a2ff9319b5…
Additional Listing Data#
Finished product Yes
Brand name base Brimonidine tartrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRIMONIDINE TARTRATE 1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861204 Internal RxNorm lookup 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 82182-321-05 Brimonidine tartrate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 11 82182-321-05 Brimonidine tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 11 82182-321-10 Brimonidine tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 11 82182-321-10 Brimonidine tartrate 10 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 10 11 82182-321-15 Brimonidine tartrate 1 in 1 CARTON SOLUTION/ DROPS 1 11 82182-321-15 Brimonidine tartrate 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82182-321 BRIMONIDINE TARTRATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 10 Current NDC, 6 package rows 20250426_5c4aea88-95ca-4da8-a3da-02f10c8b6623.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 82182-321-05 82182032105 1 BOTTLE, DROPPER in 1 CARTON (82182-321-05) / 5 mL in 1 BOTTLE, DROPPER 2024-01-02 No No Current 82182-321-10 82182032110 1 BOTTLE, DROPPER in 1 CARTON (82182-321-10) / 10 mL in 1 BOTTLE, DROPPER 2024-01-02 No No Current 82182-321-15 82182032115 1 BOTTLE, DROPPER in 1 CARTON (82182-321-15) / 15 mL in 1 BOTTLE, DROPPER 2024-01-02 No No Current