fml forte

Generic: fluorometholone

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fml forte
Generic Name fluorometholone
Labeler allergan, inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

fluorometholone 2.5 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 11980-228
Product ID 11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019216
Listing Expiration 2026-12-31
Marketing Start 1986-05-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11980228
Hyphenated Format 11980-228

Supplemental Identifiers

RxCUI
208420 310376
UPC
0311980228057
UNII
SV0CSG527L
NUI
N0000175576 N0000175450

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 fml forte (source: ndc)
Generic Name fluorometholone (source: ndc)
Application Number NDA019216 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

11980-228-05 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER 11980-228-10 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

fluorometholone (2.5 mg/mL)

Linked Drug Pages (1)

FML FORTE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "45789d76-a9c1-4ac5-84a1-fa2f9db729d9", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0311980228057"], "unii": ["SV0CSG527L"], "rxcui": ["208420", "310376"], "spl_set_id": ["b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (11980-228-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "11980-228-05", "marketing_start_date": "19860501"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (11980-228-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "11980-228-10", "marketing_start_date": "19860501"}], "brand_name": "FML FORTE", "product_id": "11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "11980-228", "generic_name": "fluorometholone", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FML FORTE", "active_ingredients": [{"name": "FLUOROMETHOLONE", "strength": "2.5 mg/mL"}], "application_number": "NDA019216", "marketing_category": "NDA", "marketing_start_date": "19860501", "listing_expiration_date": "20261231"}