Home NDC 0065-4147 SIMBRINZA
Product NDC 0065-4147
11-digit product format 000654147
Labeler code 0065
Product ID 0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brinzolamide/brimonidine tartrate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA204251
Marketing category NDA
Marketing start 2013-05-06
Substance BRIMONIDINE TARTRATE; BRINZOLAMIDE
Active strength 2; 10 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-09-29 23:25 UTC 2022-09 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N204251-001 SIMBRINZA 0.2%;1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2013-04-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2019-12-13 00:20 UTC 2019-12 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204251-001 9044484 2030-10-30 Drug product 2015-06-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204251-001 9421265 2030-06-17 Drug product 2016-10-24 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base SIMBRINZA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRINZOLAMIDE 2 mg/mL BRIMONIDINE TARTRATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9451Z89515 Internal UNII lookup 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 1421451 Internal RxNorm lookup 1421456 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 0065-4147-25 SIMBRINZA 2.5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 2.5 19 0065-4147-25 SIMBRINZA 1 in 1 CARTON SUSPENSION/ DROPS 1 19 0065-4147-27 SIMBRINZA 8 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 8 19 0065-4147-27 SIMBRINZA 1 in 1 CARTON SUSPENSION/ DROPS 1 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Brimonidine Tartrate ACTIVE INGREDIENT 4S9CL2DY2H SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Brinzolamide ACTIVE INGREDIENT 9451Z89515 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Brimonidine ACTIVE MOIETY E6GNX3HHTE SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Brinzolamide ACTIVE MOIETY 9451Z89515 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT HHT01ZNK31 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Mannitol INACTIVE INGREDIENT 3OWL53L36A SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Tyloxapol INACTIVE INGREDIENT Y27PUL9H56 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8 Water INACTIVE INGREDIENT 059QF0KO0R SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-4147 SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 19 Current NDC, Legacy NDC, 4 package rows 20250316_a49c157e-6310-0011-7b7f-e26fc1820d59.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 · 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 ndc (product): 0065-4147
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-4147-25 00065414725 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER 2013-05-06 0000-00-00 Yes No Current 0065-4147-27 00065414727 1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER 2013-05-06 0000-00-00 No No Current