Prolensa

Product NDC: 24208-602
11-digit product format: 242080602
Labeler code: 24208
Product ID: 24208-602_5114fa15-9db8-23b9-e063-6294a90ad057
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bromfenac Sodium
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA203168
Marketing category: NDA
Marketing start: 2013-04-05
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	24208-602	24208-602-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203168-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203168-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203168-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203168-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203168-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203168-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203168-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203168-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203168-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203168-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203168-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203168-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203168-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203168-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203168-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203168-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203168-001	AB	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203168-001	AB	1	`a50c72e98297…`

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: Prolensa
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1375917	Internal RxNorm lookup
1375922	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4e072537-f73c-4a96-a65f-e2805ce112d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e42b5738-f3b2-36cb-547c-d658794618bc	Product name	2	20250804
4ce8f27b-067c-45ad-b8f6-4b29ec66e497	Product name	2	20250115
b81a1117-443d-49e4-a709-58c3c32468af	Product name	5	20241010
ee6f8cae-1597-1a7e-3fb9-6aaeba954efe	Product name	3	20150902
8442aba0-7521-47cb-8a4e-c9896f35e8ae	Product name	3	20150317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
24208-602-01	Prolensa	1.6 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	1.6	19
24208-602-01	Prolensa	1 in 1 CARTON	SOLUTION/ DROPS	1	19
24208-602-03	Prolensa	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3	19
24208-602-03	Prolensa	1 in 1 CARTON	SOLUTION/ DROPS	1	19
24208-602-04	Prolensa	1 in 1 CARTON	SOLUTION/ DROPS	1	19
24208-602-04	Prolensa	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3	19
24208-602-06	Prolensa	1 in 1 CARTON	SOLUTION/ DROPS	1	19
24208-602-06	Prolensa	0.6 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	0.6	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-602-01	ML - Milliliter	24208-602	3683772a-db3f-4178-84ca-d664b5a63640	1	2013-05-02
24208-602-03	ML - Milliliter	24208-602	7da1f353-3779-4a4b-9750-afafce6cd5c5	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMFENAC SODIUM	ACTIVE INGREDIENT	8ECV571Y37	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
BROMFENAC	ACTIVE MOIETY	864P0921DW	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-602	PROLENSA (BROMFENAC SODIUM) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]	17	Current NDC, Legacy NDC, 8 package rows	20250302_4e072537-f73c-4a96-a65f-e2805ce112d8.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bromfenac ophthalmic solution	BROMFENAC SODIUM	Bausch & Lomb Americas Inc.	246e2110-6a2d-4e22-8e37-72d80796b9af	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203168 application number: NDA203168
Prolensa	BROMFENAC SODIUM	Bausch & Lomb Incorporated	4e072537-f73c-4a96-a65f-e2805ce112d8	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203168 application number: NDA203168 ndc (product): 24208-602
bromfenac ophthalmic solution	BROMFENAC SODIUM	Dr. Reddy's Laboratories Inc.	fa249b9e-931c-454d-ba06-33139d5580e7	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203168 application number: NDA203168

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ECV571Y37	BROMFENAC SODIUM	120638-55-3	BROMFENAC SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1375917	bromfenac 0.07 % Ophthalmic Solution	PSN	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375922	PROLENSA 0.07 % Ophthalmic Solution	PSN	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375922	bromfenac 0.7 MG/ML Ophthalmic Solution [Prolensa]	SBD	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375917	bromfenac 0.7 MG/ML Ophthalmic Solution	SCD	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375917	bromfenac 0.07 % Ophthalmic Solution	SY	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375917	bromfenac 0.7 MG/ML (as bromfenac sodium 0.805 MG/ML) Ophthalmic Solution	SY	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375922	Prolensa (bromfenac 0.07 % (as bromfenac sodium 0.0805 % )) Ophthalmic Solution	SY	4e072537-f73c-4a96-a65f-e2805ce112d8	19
1375922	Prolensa 0.7 MG/ML Ophthalmic Solution	SY	4e072537-f73c-4a96-a65f-e2805ce112d8	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-602-01	24208060201	1.6 mL in 1 BOTTLE, DROPPER	1.6 ml					Historical
24208-602-03	24208060203	1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER		2013-04-05	0000-00-00	No	No	Current
24208-602-04	24208060204	1 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER		2013-04-05	0000-00-00	No	No	Current
24208-602-06	24208060206	1 BOTTLE, DROPPER in 1 CARTON (24208-602-06) / .6 mL in 1 BOTTLE, DROPPER		2013-04-05	0000-00-00	Yes	No	Current