Home NDC 0078-0904-98 SIMBRINZA
Product NDC 0078-0904
Requested package NDC 0078-0904-98
11-digit product format 000780904
Labeler code 0078
Product ID 0078-0904_c2a9e73d-9414-489a-9840-aa8aae4cdd00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brinzolamide/brimonidine tartrate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA204251
Marketing category NDA
Marketing start 2013-05-01
Marketing end 2023-02-28
Substance BRIMONIDINE TARTRATE; BRINZOLAMIDE
Active strength 2 mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N204251-001 SIMBRINZA BRIMONIDINE TARTRATE; BRINZOLAMIDE 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204251-001 9421265 2030-06-17 Drug product 2016-10-24 N204251-001 9044484 2030-10-30 Drug product 2015-06-09
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 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 3 · 90 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204251-001 6316441 2019-12-07 U-778 2013-09-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SIMBRINZA BRINZOLAMIDE/BRIMONIDINE TARTRATE Alcon Laboratories, Inc. a49c157e-6310-0011-7b7f-e26fc1820d59 2025-03-11 Warnings, Adverse reactions Exact identifier application applno (NDA): 204251 application number: NDA204251
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0904-98 00078090498 1 BOTTLE in 1 CARTON (0078-0904-98) > 2.5 mL in 1 BOTTLE 1 bottle 2020-08-04 2023-02-28 Yes No Current