Bromfenac

Product NDC: 68180-436
11-digit product format: 681800436
Labeler code: 68180
Product ID: 68180-436_8df89f04-52dd-4d9c-8cf3-9c045e669463
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bromfenac
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA202903
Marketing category: ANDA
Marketing start: 2024-02-02
Substance: BROMFENAC SODIUM
Active strength: .9 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: 2026-12-31
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
A202903-001	BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2023-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202903-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202903-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2023-08-15	`a50c72e98297…`

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	A202903-001	AT2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202903-001	AT2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202903-001	AT2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202903-001	AT2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202903-001	AT2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202903-001	AT2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202903-001	AT2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202903-001	AT2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202903-001	AT2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202903-001	AT2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202903-001	AT2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202903-001	AT2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202903-001	AT2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202903-001	AT2	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202903-001	AT2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202903-001	AT2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202903-001	AT2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202903-001	AT2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202903-001	AT2	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202903-001	AT2	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bromfenac
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BROMFENAC SODIUM	.9 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
578018	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
2fc689b7-d5ba-4591-8c23-b48e588d7a28	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	Strength	SPL version
68180-436-01	Bromfenac	1.7 mL in 1 BOTTLE	SOLUTION	1.7		5
68180-436-01	Bromfenac	1 in 1 CARTON	SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-436-01	ML - Milliliter	68180-436	74212b72-316a-47b2-bfe5-6dd8d11e4c36	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-436	BROMFENAC SOLUTION [LUPIN PHARMACEUTICALS, INC.]	4	Current NDC, 2 package rows	20250119_2fc689b7-d5ba-4591-8c23-b48e588d7a28.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	Lupin Pharmaceuticals, Inc.	2fc689b7-d5ba-4591-8c23-b48e588d7a28	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202903 application number: ANDA202903 ndc (product): 68180-436

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	2fc689b7-d5ba-4591-8c23-b48e588d7a28	5
578018	bromfenac 0.9 MG/ML Ophthalmic Solution	SCD	2fc689b7-d5ba-4591-8c23-b48e588d7a28	5
578018	bromfenac 0.09 % Ophthalmic Solution	SY	2fc689b7-d5ba-4591-8c23-b48e588d7a28	5
578018	bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic Solution	SY	2fc689b7-d5ba-4591-8c23-b48e588d7a28	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68180-436-01	68180043601	1 BOTTLE in 1 CARTON (68180-436-01) / 1.7 mL in 1 BOTTLE	1 bottle	2024-02-02	No	No	Current