flarex

Generic: fluorometholone acetate

Labeler: eyevance pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name flarex
Generic Name fluorometholone acetate
Labeler eyevance pharmaceuticals
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

fluorometholone acetate 1 mg/mL

Manufacturer
Eyevance Pharmaceuticals

Identifiers & Regulatory

Product NDC 71776-100
Product ID 71776-100_2bed0334-e39e-c18b-e063-6294a90af598
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019079
Listing Expiration 2026-12-31
Marketing Start 2019-03-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71776100
Hyphenated Format 71776-100

Supplemental Identifiers

RxCUI
1249629 1249631
UPC
0371776100059 0371776100035
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 (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

71776-100-03 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTIC 71776-100-05 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) / 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": "2bed0334-e39e-c18b-e063-6294a90af598", "openfda": {"upc": ["0371776100059", "0371776100035"], "unii": ["9I50C3I3OK"], "rxcui": ["1249629", "1249631"], "spl_set_id": ["19918ea5-8568-44d6-b8ee-7b2197cee85c"], "manufacturer_name": ["Eyevance Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03)  / 2.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "71776-100-03", "marketing_start_date": "20220101"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "71776-100-05", "marketing_start_date": "20190305"}], "brand_name": "Flarex", "product_id": "71776-100_2bed0334-e39e-c18b-e063-6294a90af598", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71776-100", "generic_name": "fluorometholone acetate", "labeler_name": "Eyevance Pharmaceuticals", "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": "20190305", "listing_expiration_date": "20261231"}