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 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 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 2026-08-18 06:07:40 2026-07 A211914-001 BRINZOLAMIDE 1% SUSPENSION/DROPS / OPHTHALMIC 2023-07-28 caaa826d4ba7…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…
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
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 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