Home DailyMed fd89ebce-6142-472f-9785-ea377bb592e6 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:13:25
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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 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 · 43 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 2026-09-14 22:38:34 2026-08 N021770-001 ALPHAGAN P 0.1% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2005-08-19 84e616aacf4f…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…
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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.