Home NDC 0065-0275-15 Azopt
Product NDC 0065-0275
Requested package NDC 0065-0275-15
11-digit product format 000650275
Labeler code 0065
Product ID 0065-0275_dd67a0fc-df84-410f-81ef-7dadea018f21
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brinzolamide
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA020816
Marketing category NDA
Marketing start 1998-04-30
Marketing end 0000-00-00
Substance BRINZOLAMIDE
Active strength 10 mg/mL
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 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 N020816-001 AZOPT BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020816-001 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 · 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 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1998-04-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1998-04-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1998-04-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1998-04-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1998-04-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BRINZOLAMIDE ACTIVE INGREDIENT 9451Z89515 AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 BRINZOLAMIDE ACTIVE MOIETY 9451Z89515 AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R AZOPT (BRINZOLAMIDE) SUSPENSION [ALCON LABORATORIES, INC.] 6
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-0275-15 00065027515 1 BOTTLE, PLASTIC in 1 CARTON (0065-0275-15) > 15 mL in 1 BOTTLE, PLASTIC 1998-04-30 0000-00-00 No No Current