flarex

Generic: fluorometholone acetate

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name flarex
Generic Name fluorometholone acetate
Labeler harrow eye, llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

fluorometholone acetate 1 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-010
Product ID 82667-010_31ac358e-0c93-1db8-e063-6294a90ae8e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019079
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667010
Hyphenated Format 82667-010

Supplemental Identifiers

RxCUI
1249629 1249631
UPC
0382667010012 0382667010005
UNII
9I50C3I3OK

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 flarex (source: ndc)
Generic Name fluorometholone acetate (source: ndc)
Application Number NDA019079 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-00) / 2.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-01) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

82667-010-00 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-00) / 2.5 mL in 1 BOTTLE, PLASTIC 82667-010-01 1 BOTTLE, PLASTIC in 1 CARTON (82667-010-01) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

fluorometholone acetate (1 mg/mL)

Linked Drug Pages (1)

Flarex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "31ac358e-0c93-1db8-e063-6294a90ae8e5", "openfda": {"upc": ["0382667010012", "0382667010005"], "unii": ["9I50C3I3OK"], "rxcui": ["1249629", "1249631"], "spl_set_id": ["f060dec4-09dc-4266-ab4c-a6ed49cd8126"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, PLASTIC in 1 CARTON (82667-010-00)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82667-010-00", "marketing_start_date": "20250331"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (82667-010-01)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82667-010-01", "marketing_start_date": "20250331"}], "brand_name": "Flarex", "product_id": "82667-010_31ac358e-0c93-1db8-e063-6294a90ae8e5", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82667-010", "generic_name": "fluorometholone acetate", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Flarex", "active_ingredients": [{"name": "FLUOROMETHOLONE ACETATE", "strength": "1 mg/mL"}], "application_number": "NDA019079", "marketing_category": "NDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}