fluorometholone ophthalmic suspension

Generic: fluorometholone

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluorometholone ophthalmic suspension
Generic Name fluorometholone
Labeler amneal pharmaceuticals ny llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

fluorometholone 1 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1585
Product ID 60219-1585_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216348
Listing Expiration 2026-12-31
Marketing Start 2023-01-09

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 602191585
Hyphenated Format 60219-1585

Supplemental Identifiers

RxCUI
310377
UPC
0360219158665
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 fluorometholone ophthalmic suspension (source: ndc)
Generic Name fluorometholone (source: ndc)
Application Number ANDA216348 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

60219-1585-3 1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

fluorometholone (1 mg/mL)

Linked Drug Pages (1)

fluorometholone ophthalmic suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0360219158665"], "unii": ["SV0CSG527L"], "rxcui": ["310377"], "spl_set_id": ["e7988a3b-e432-4d42-a8d2-63ca017e6a01"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60219-1585-3", "marketing_start_date": "20230109"}], "brand_name": "fluorometholone ophthalmic suspension", "product_id": "60219-1585_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "60219-1585", "generic_name": "fluorometholone", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fluorometholone ophthalmic suspension", "active_ingredients": [{"name": "FLUOROMETHOLONE", "strength": "1 mg/mL"}], "application_number": "ANDA216348", "marketing_category": "ANDA", "marketing_start_date": "20230109", "listing_expiration_date": "20261231"}