prolensa

Generic: bromfenac sodium

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prolensa
Generic Name bromfenac sodium
Labeler bausch & lomb incorporated
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

bromfenac sodium .7 mg/mL

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-602
Product ID 24208-602_36f06de1-9842-0b4a-e063-6394a90a2b66
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203168
Listing Expiration 2026-12-31
Marketing Start 2013-04-05

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 24208602
Hyphenated Format 24208-602

Supplemental Identifiers

RxCUI
1375917 1375922
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 prolensa (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 (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (24208-602-06) / .6 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

24208-602-03 1 BOTTLE, DROPPER in 1 CARTON (24208-602-03) / 3 mL in 1 BOTTLE, DROPPER 24208-602-04 1 BOTTLE, DROPPER in 1 CARTON (24208-602-04) / 3 mL in 1 BOTTLE, DROPPER 24208-602-06 1 BOTTLE, DROPPER in 1 CARTON (24208-602-06) / .6 mL in 1 BOTTLE, DROPPER

Ingredients (1)

bromfenac sodium (.7 mg/mL)

Linked Drug Pages (1)

Prolensa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "36f06de1-9842-0b4a-e063-6394a90a2b66", "openfda": {"unii": ["8ECV571Y37"], "rxcui": ["1375917", "1375922"], "spl_set_id": ["4e072537-f73c-4a96-a65f-e2805ce112d8"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-602-03)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-602-03", "marketing_start_date": "20130405"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-602-04)  / 3 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-602-04", "marketing_start_date": "20130405"}, {"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (24208-602-06)  / .6 mL in 1 BOTTLE, DROPPER", "package_ndc": "24208-602-06", "marketing_start_date": "20130405"}], "brand_name": "Prolensa", "product_id": "24208-602_36f06de1-9842-0b4a-e063-6394a90a2b66", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "24208-602", "generic_name": "Bromfenac Sodium", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prolensa", "active_ingredients": [{"name": "BROMFENAC SODIUM", "strength": ".7 mg/mL"}], "application_number": "NDA203168", "marketing_category": "NDA", "marketing_start_date": "20130405", "listing_expiration_date": "20261231"}