fml

Generic: fluorometholone

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

Drug Facts

Product Profile

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

fluorometholone 1 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 11980-211
Product ID 11980-211_000b0dad-a290-4a62-81ec-208e0a9c058b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016851
Listing Expiration 2026-12-31
Marketing Start 1972-02-01

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 11980211
Hyphenated Format 11980-211

Supplemental Identifiers

RxCUI
310377 545243
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 (source: ndc)
Generic Name fluorometholone (source: ndc)
Application Number NDA016851 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

11980-211-05 1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER 11980-211-10 1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

fluorometholone (1 mg/mL)

Linked Drug Pages (1)

FML ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "000b0dad-a290-4a62-81ec-208e0a9c058b", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["SV0CSG527L"], "rxcui": ["310377", "545243"], "spl_set_id": ["c374d65a-35b5-4c9e-9069-5148875dc4df"], "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 (11980-211-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "11980-211-05", "marketing_start_date": "19720201"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (11980-211-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "11980-211-10", "marketing_start_date": "19720201"}], "brand_name": "FML", "product_id": "11980-211_000b0dad-a290-4a62-81ec-208e0a9c058b", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "11980-211", "generic_name": "fluorometholone", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FML", "active_ingredients": [{"name": "FLUOROMETHOLONE", "strength": "1 mg/mL"}], "application_number": "NDA016851", "marketing_category": "NDA", "marketing_start_date": "19720201", "listing_expiration_date": "20261231"}