bromfenac ophthalmic solution

Generic: bromfenac sodium

Labeler: dr. reddy's laboratories 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 dr. reddy's laboratories inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .7 mg/mL

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 75907-093
Product ID 75907-093_36f161c2-fd2f-72fe-e063-6394a90a370c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203168
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

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 75907093
Hyphenated Format 75907-093

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 (75907-093-03) / 3 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

75907-093-03 1 BOTTLE, DROPPER in 1 CARTON (75907-093-03) / 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": "36f161c2-fd2f-72fe-e063-6394a90a370c", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1375917"], "spl_set_id": ["fa249b9e-931c-454d-ba06-33139d5580e7"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (75907-093-03)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "75907-093-03", "marketing_start_date": "20240715"}], "brand_name": "bromfenac ophthalmic solution", "product_id": "75907-093_36f161c2-fd2f-72fe-e063-6394a90a370c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "75907-093", "generic_name": "Bromfenac Sodium", "labeler_name": "Dr. Reddy's Laboratories 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": "20240715", "listing_expiration_date": "20261231"}