bromfenac ophthalmic solution

Generic: bromfenac sodium

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name bromfenac ophthalmic solution
Generic Name bromfenac sodium
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .7 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-602
Product ID 82260-602_36f16fe4-94b2-706c-e063-6394a90af158
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203168
Listing Expiration 2026-12-31
Marketing Start 2024-01-08

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260602
Hyphenated Format 82260-602

Supplemental Identifiers

RxCUI
1375917
UNII
8ECV571Y37

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bromfenac ophthalmic solution (source: ndc)
Generic Name bromfenac sodium (source: ndc)
Application Number NDA203168 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .7 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

82260-602-03 1 BOTTLE, DROPPER in 1 CARTON (82260-602-03) / 3 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.7 mg/mL)

Linked Drug Pages (1)

bromfenac ophthalmic solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "36f16fe4-94b2-706c-e063-6394a90af158", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1375917"], "spl_set_id": ["246e2110-6a2d-4e22-8e37-72d80796b9af"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-602-03)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-602-03", "marketing_start_date": "20240108"}], "brand_name": "bromfenac ophthalmic solution", "product_id": "82260-602_36f16fe4-94b2-706c-e063-6394a90af158", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "82260-602", "generic_name": "Bromfenac Sodium", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "bromfenac ophthalmic solution", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".7 mg/mL"}], "application_number": "NDA203168", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240108", "listing_expiration_date": "20261231"}