Home NDC 0078-0722-10 Azopt
Product NDC 0078-0722
Requested package NDC 0078-0722-10
11-digit product format 000780722
Labeler code 0078
Product ID 0078-0722_4a9f4516-bb9d-49a5-a8c6-fcd82063b63f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brinzolamide
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
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 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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0722 AZOPT (BRINZOLAMIDE) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 4 Legacy NDC 20230708_acc89925-3ee3-4632-98ae-38a546848346.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0722-10 00078072210 1 BOTTLE in 1 CARTON (0078-0722-10) > 10 mL in 1 BOTTLE 1 bottle 2021-12-24 0000-00-00 No No Current