Home NDC 49708-755 bromfenac
Product NDC 49708-755
11-digit product format 497080755
Labeler code 49708
Product ID 49708-755_47dae14d-3f32-0889-e063-6294a90aa707
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bromfenac
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA206911
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-02-07
Substance BROMFENAC SODIUM
Active strength .76 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 N206911-001 BROMSITE BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N206911-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26
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 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2016-04-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206911-001 BROMSITE EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC RLD, RS 2016-04-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 41 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 N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206911-001 RE50218 2029-03-05 U-1834 Drug product 2024-12-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206911-001 8778999 2029-08-07 U-1834 Drug product 2016-05-05 cb3db0bc1861…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N206911-001 NP 2019-04-08 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N206911-001 NP 2019-04-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206911-001 NP 2019-04-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206911-001 NP 2019-04-08 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base bromfenac
Brand name suffix 0.075%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMFENAC SODIUM .76 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 1790141 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 49708-755-41 bromfenac0.075% 1 in 1 CARTON SOLUTION/ DROPS 1 2 49708-755-41 bromfenac0.075% 1 in 1 POUCH SOLUTION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49708-755 BROMFENAC 0.075% (BROMFENAC) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] 1 Current NDC, 2 package rows 20240208_7d723a00-4822-4e04-aa22-21de22009d0a.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 49708-755-41 49708075541 1 POUCH in 1 CARTON (49708-755-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER 1 pouch 2024-02-07 No No Current