fluorometholone ophthalmic suspension

Product NDC
60219-1586
11-digit product format
602191586
Labeler code
60219
Product ID
60219-1586_6cb30deb-0a3d-4686-bcab-3f7cfbe5ac23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluorometholone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216348
Marketing category
ANDA
Marketing start
2023-01-09
Substance
FLUOROMETHOLONE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
SV0CSG527LFLUOROMETHOLONE426-13-1FLUOROMETHOLONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-1586-6602191586061 BOTTLE, DROPPER in 1 CARTON (60219-1586-6) / 10 mL in 1 BOTTLE, DROPPER2023-01-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluorometholone Ophthalmic Suspension USP, 0.1% sterileAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC2024-01-09HUMAN PRESCRIPTION DRUG LABEL6