BROMSITE

Product NDC: 49708-754
11-digit product format: 497080754
Labeler code: 49708
Product ID: 49708-754_47daa628-c56f-1e9d-e063-6294a90a3d33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bromfenac
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA206911
Marketing category: NDA
Marketing start: 2016-05-01
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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206911-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206911-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206911-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206911-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206911-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206911-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206911-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206911-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206911-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206911-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206911-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206911-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206911-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206911-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206911-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206911-001	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N206911-001	AB	1	`a50c72e98297…`

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: BROMSITE
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1790141	Internal RxNorm lookup
1790146	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
144a5072-341b-4591-8705-773b63044bcc	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
ee6f8cae-1597-1a7e-3fb9-6aaeba954efe	Product name	3	20150902
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
8442aba0-7521-47cb-8a4e-c9896f35e8ae	Product name	3	20150317
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49708-754-41	BROMSITE0.075%	1 in 1 CARTON	SOLUTION/ DROPS	1		5
49708-754-41	BROMSITE0.075%	1 in 1 POUCH	SOLUTION/ DROPS	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49708-754-41	ML - Milliliter	49708-754	b9301b52-8528-4edf-8661-d5f0a3fab922	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49708-754	BROMSITE 0.075% (BROMFENAC) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20230415_144a5072-341b-4591-8705-773b63044bcc.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BROMSITE 0.075%	BROMFENAC	Sun Pharmaceutical Industries, Inc.	144a5072-341b-4591-8705-773b63044bcc	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206911 application number: NDA206911 ndc (product): 49708-754
bromfenac 0.075%	BROMFENAC	Sun Pharmaceutical Industries, Inc.	7d723a00-4822-4e04-aa22-21de22009d0a	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206911 application number: NDA206911

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
1790141	bromfenac 0.075 % Ophthalmic Solution	PSN	144a5072-341b-4591-8705-773b63044bcc	5
1790146	BromSite 0.075 % Ophthalmic Solution	PSN	144a5072-341b-4591-8705-773b63044bcc	5
1790146	bromfenac 0.75 MG/ML Ophthalmic Solution [Bromsite]	SBD	144a5072-341b-4591-8705-773b63044bcc	5
1790141	bromfenac 0.75 MG/ML Ophthalmic Solution	SCD	144a5072-341b-4591-8705-773b63044bcc	5
1790141	bromfenac 0.075 % Ophthalmic Solution	SY	144a5072-341b-4591-8705-773b63044bcc	5
1790141	bromfenac 0.75 MG/ML (as bromfenac sodium 0.81 MG/ML) Ophthalmic Solution	SY	144a5072-341b-4591-8705-773b63044bcc	5
1790146	Bromsite 0.075 % Ophthalmic Solution	SY	144a5072-341b-4591-8705-773b63044bcc	5
1790146	Bromsite 0.75 MG/ML (as bromfenac sodium 0.81 MG/ML) Ophthalmic Solution	SY	144a5072-341b-4591-8705-773b63044bcc	5
1790146	Bromsite 0.75 MG/ML Ophthalmic Solution	SY	144a5072-341b-4591-8705-773b63044bcc	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49708-754-41	49708075441	1 POUCH in 1 CARTON (49708-754-41) / 1 BOTTLE, DROPPER in 1 POUCH / 5 mL in 1 BOTTLE, DROPPER	1 pouch	2016-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BROMSITE 0.075%	Sun Pharmaceutical Industries, Inc. \| Woodstock Sterile Solutions, Inc.	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	5