bromfenac

Product NDC: 50383-249
11-digit product format: 503830249
Labeler code: 50383
Product ID: 50383-249_835249a6-2d83-4ecd-b2a4-4539e2f8709d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bromfenac
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA203395
Marketing category: ANDA
Marketing start: 2014-01-22
Marketing end: 0000-00-00
Substance: BROMFENAC SODIUM
Active strength: 1 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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50383-249		I	Inactivated by FDA		2026-08-03
excluded package	package	50383-249	50383-249-71	I	Inactivated by FDA		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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-249-71	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-249-71	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-249-71	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-249-71	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-249-71	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-249-71	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-249-71	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-249-71	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-249-71	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-249-71	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-249-71	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-249-71	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-249-71	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-249-71	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-249-71	`1332a3947898…`	`d4bfe170f9cd…`

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
A203395-001	BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A203395-001	AT2

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	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2014-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203395-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	RS	2014-01-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203395-001	AT2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203395-001	AT2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203395-001	AT2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203395-001	AT2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203395-001	AT2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203395-001	AT2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203395-001	AT2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203395-001	AT2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203395-001	AT2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203395-001	AT2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203395-001	AT2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203395-001	AT2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203395-001	AT2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203395-001	AT2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203395-001	AT2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203395-001	AT2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203395-001	AT2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203395-001	AT2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203395-001	AT2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203395-001	AT2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203395-001	AT2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203395-001	AT2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203395-001	AT2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203395-001	AT2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203395-001	AT2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203395-001	AT2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203395-001	AT2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203395-001	AT2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203395-001	AT2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203395-001	AT2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203395-001	AT2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203395-001	AT2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203395-001	AT2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203395-001	AT2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203395-001	AT2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203395-001	AT2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203395-001	AT2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203395-001	AT2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203395-001	AT2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203395-001	AT2	1	`cb3db0bc1861…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-249-71	2024-01-30	C162847	48780-1	1030e365-47b2-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Bromfenac Ophthalmic Solution safely and effectively. See full prescribing information for bromfenac. Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50383-249-71	bromfenac	1 in 1 CARTON	SOLUTION/ DROPS	1		8
50383-249-71	bromfenac	1.7 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	1.7		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-249-71	ML - Milliliter	50383-249	3ab22a0b-8050-4752-bbba-1bdeab13b231	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMFENAC SODIUM	ACTIVE INGREDIENT	8ECV571Y37	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
BROMFENAC	ACTIVE MOIETY	864P0921DW	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	BROMFENAC SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-249	BROMFENAC SOLUTION/ DROPS [AKORN]	8	Legacy NDC, 2 package rows	20220312_e853723e-8419-4444-89e9-ee3f571b0974.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bromfenac	BROMFENAC	ARMAS PHARMACEUTICALS INC.	08a0591e-6cb3-30ce-e063-6394a90a33fb	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203395 application number: ANDA203395

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ECV571Y37	BROMFENAC SODIUM	120638-55-3	BROMFENAC SODIUM
864P0921DW	BROMFENAC	91714-94-2	bromfenac

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
578018	bromfenac 0.09 % Ophthalmic Solution	PSN	e853723e-8419-4444-89e9-ee3f571b0974	8
578018	bromfenac 0.9 MG/ML Ophthalmic Solution	SCD	e853723e-8419-4444-89e9-ee3f571b0974	8
578018	bromfenac 0.09 % Ophthalmic Solution	SY	e853723e-8419-4444-89e9-ee3f571b0974	8
578018	bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic Solution	SY	e853723e-8419-4444-89e9-ee3f571b0974	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-249-71	50383024971	1 BOTTLE, DROPPER in 1 CARTON (50383-249-71) > 1.7 mL in 1 BOTTLE, DROPPER	2014-01-22	0000-00-00	No	No	Current