Home NDC 68682-464 BRINZOLAMIDE
Product NDC 68682-464
11-digit product format 686820464
Labeler code 68682
Product ID 68682-464_4fe88efe-d05e-0f99-e063-6294a90a51d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brinzolamide
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Oceanside Pharmaceuticals.
Application ANDA204884
Marketing category ANDA
Marketing start 2021-08-25
Marketing end 2028-01-31
Substance BRINZOLAMIDE
Active strength 10 mg/mL
Pharmacologic classes Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag No
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 A204884-001 BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204884-001 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.
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 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204884-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2021-08-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base BRINZOLAMIDE 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 68682-464-10 BRINZOLAMIDE 1 in 1 CARTON SUSPENSION/ DROPS 1 2 68682-464-10 BRINZOLAMIDE 10 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 10 2 68682-464-15 BRINZOLAMIDE 15 mL in 1 BOTTLE, PLASTIC SUSPENSION/ DROPS 15 2 68682-464-15 BRINZOLAMIDE 1 in 1 CARTON SUSPENSION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-464 BRINZOLAMIDE SUSPENSION/ DROPS [OCEANSIDE PHARMACEUTICALS.] 1 Current NDC, Legacy NDC, 4 package rows 20210827_fb7229d4-522e-4cb2-b513-9d34f3ded591.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 68682-464-10 68682046410 1 BOTTLE, PLASTIC in 1 CARTON (68682-464-10) / 10 mL in 1 BOTTLE, PLASTIC 2021-08-25 2028-01-31 No No Current 68682-464-15 68682046415 1 BOTTLE, PLASTIC in 1 CARTON (68682-464-15) / 15 mL in 1 BOTTLE, PLASTIC 2021-08-25 2028-01-31 No No Current