Home NDC 82260-602 bromfenac ophthalmic solution
Product NDC 82260-602
11-digit product format 822600602
Labeler code 82260
Product ID 82260-602_5114ef85-6052-bb94-e063-6294a90a1abc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bromfenac Sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Americas Inc.
Application NDA203168
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-01-08
Substance BROMFENAC SODIUM
Active strength .7 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 N203168-001 PROLENSA BROMFENAC SODIUM EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N203168-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203168-001 10085958 2032-11-19 Drug product 2018-10-15 N203168-001 9517220 2033-11-11 U-1933 2017-01-11
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 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2013-04-05 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 401 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203168-001 8129431 2025-09-11 Drug substance, Drug product 2013-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203168-001 8129431 2025-09-11 Drug substance, Drug product 2013-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203168-001 8129431 2025-09-11 Drug substance, Drug product 2013-05-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203168-001 8129431 2025-09-11 Drug substance, Drug product 2013-05-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8669290 2024-01-16 Drug product 2014-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8754131 2024-01-16 Drug product 2014-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8871813 2024-01-16 Drug product 2014-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8927606 2024-01-16 U-100 2015-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8927606 2024-01-16 U-810 2015-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8927606 2024-01-16 U-1095 2015-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 9144609 2024-01-16 Drug product 2015-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 9561277 2024-01-16 U-1933 2017-03-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 8129431 2025-09-11 Drug substance, Drug product 2013-05-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8669290 2024-01-16 Drug product 2014-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8754131 2024-01-16 Drug product 2014-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8871813 2024-01-16 Drug product 2014-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8927606 2024-01-16 U-100 2015-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8927606 2024-01-16 U-810 2015-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8927606 2024-01-16 U-1095 2015-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 9144609 2024-01-16 Drug product 2015-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 9561277 2024-01-16 U-1933 2017-03-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 8129431 2025-09-11 Drug substance, Drug product 2013-05-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203168-001 8669290 2024-01-16 Drug product 2014-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203168-001 8754131 2024-01-16 Drug product 2014-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203168-001 8871813 2024-01-16 Drug product 2014-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203168-001 8927606 2024-01-16 U-100 2015-01-12 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base bromfenac ophthalmic solution
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMFENAC SODIUM .7 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ECV571Y37 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1375917 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 82260-602-03 bromfenac ophthalmic solution 3 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 3 6 82260-602-03 bromfenac ophthalmic solution 1 in 1 CARTON SOLUTION/ DROPS 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82260-602 BROMFENAC OPHTHALMIC SOLUTION (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB AMERICAS INC.] 3 Current NDC, 2 package rows 20240822_246e2110-6a2d-4e22-8e37-72d80796b9af.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82260-602-03 82260060203 1 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER 2024-01-08 No No Current