Home NDC 72162-2201 BRINZOLAMIDE
Product NDC 72162-2201
11-digit product format 721622201
Labeler code 72162
Product ID 72162-2201_584621b7-07b3-45c9-8e3d-8f21391cf3f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brinzolamide
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Bryant Ranch Prepack
Application ANDA211914
Marketing category ANDA
Marketing start 2023-10-10
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 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 A211914-001 BRINZOLAMIDE BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC 2023-07-28
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 2026-02-19 14:30 UTC 2026-02 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC 2023-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC 2023-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC 2023-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC AB 2023-07-28 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC 2023-07-28 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211914-001 CGT 2024-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211914-001 CGT 2024-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211914-001 CGT 2024-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211914-001 CGT 2024-04-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211914-001 CGT 2024-04-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211914-001 CGT 2024-04-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211914-001 CGT 2024-04-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211914-001 CGT 2024-04-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211914-001 CGT 2024-04-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211914-001 CGT 2024-04-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211914-001 CGT 2024-04-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211914-001 CGT 2024-04-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211914-001 CGT 2024-04-07 a72a2bbeb626…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 72162-2201-2 BRINZOLAMIDE 1 in 1 CARTON SUSPENSION/ DROPS 1 100 72162-2201-2 BRINZOLAMIDE 10 mL in 1 BOTTLE SUSPENSION/ DROPS 10 100 72162-2201-4 BRINZOLAMIDE 15 mL in 1 BOTTLE SUSPENSION/ DROPS 15 100 72162-2201-4 BRINZOLAMIDE 1 in 1 CARTON SUSPENSION/ DROPS 1 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2201 BRINZOLAMIDE SUSPENSION/ DROPS [BRYANT RANCH PREPACK] 100 Current NDC, 4 package rows 20231223_460baf5f-1d47-4ae0-b635-84507c3b028d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2201-2 72162220102 1 BOTTLE in 1 CARTON (72162-2201-2) / 10 mL in 1 BOTTLE 1 bottle 2023-12-19 No No Current 72162-2201-4 72162220104 1 BOTTLE in 1 CARTON (72162-2201-4) / 15 mL in 1 BOTTLE 1 bottle 2023-12-19 No No Current