Home NDC 0781-6014 Brinzolamide
Product NDC 0781-6014
11-digit product format 007816014
Labeler code 0781
Product ID 0781-6014_dff324e7-139a-429e-989e-9d1ac7433d75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Brinzolamide
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Sandoz Inc
Application NDA020816
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2021-03-08
Substance BRINZOLAMIDE
Active strength 10 mg/mL
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
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 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 · 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 N020816-001 AZOPT 1% SUSPENSION/DROPS / OPHTHALMIC AB RLD, RS 1998-04-01 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Brinzolamide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BRINZOLAMIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9451Z89515 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308805 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 0781-6014-70 Brinzolamide 10 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 10 4 0781-6014-70 Brinzolamide 1 in 1 CARTON SUSPENSION/ DROPS 1 4 0781-6014-85 Brinzolamide 15 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 15 4 0781-6014-85 Brinzolamide 1 in 1 CARTON SUSPENSION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-6014 BRINZOLAMIDE SUSPENSION/ DROPS [SANDOZ INC] 3 Current NDC, Legacy NDC, 4 package rows 20240502_ed6dbc25-47d7-42db-9787-5814d71f45ce.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 Marketing end Sample Exclude flag Status 0781-6014-70 00781601470 1 BOTTLE, PLASTIC in 1 CARTON (0781-6014-70) / 10 mL in 1 BOTTLE, PLASTIC 2021-03-08 0000-00-00 No No Current 0781-6014-85 00781601485 1 BOTTLE, PLASTIC in 1 CARTON (0781-6014-85) / 15 mL in 1 BOTTLE, PLASTIC 2021-03-08 0000-00-00 No No Current