Home DailyMed 3683772a-db3f-4178-84ca-d664b5a63640 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-05-02
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:06:34 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203168-001 PROLENSA EQ 0.07% ACID SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2013-04-05 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 407 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N203168-001 10085958 2032-11-19 Drug product 2018-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N203168-001 9517220 2033-11-11 U-1933 2017-01-11 caaa826d4ba7…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…
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.