Home NDC 68180-434 BROMFENAC
Product NDC 68180-434
11-digit product format 681800434
Labeler code 68180
Product ID 68180-434_bde2565a-075e-4910-874b-9737d0ed9ccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BROMFENAC
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA211239
Marketing category ANDA
Marketing start 2024-02-12
Substance BROMFENAC SODIUM
Active strength .75 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 A211239-001 BROMFENAC SODIUM BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211239-001 AB
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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211239-001 BROMFENAC SODIUM EQ 0.075% ACID SOLUTION/DROPS / OPHTHALMIC AB 2024-02-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base BROMFENAC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BROMFENAC SODIUM .75 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 1790141 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-434-01 BROMFENAC 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 7 68180-434-01 BROMFENAC 1 in 1 CARTON SOLUTION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-434 BROMFENAC SOLUTION/ DROPS [LUPIN PHARMACEUTICALS, INC.] 6 Current NDC, 2 package rows 20250221_2b2621e7-a69e-4286-a7e7-0fc31a91fe29.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68180-434-01 68180043401 1 BOTTLE in 1 CARTON (68180-434-01) / 5 mL in 1 BOTTLE 1 bottle 2024-02-12 No No Current