loteprednol etabonate

Generic: loteprednol etabonate

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler padagis us llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 2 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-4080
Product ID 0574-4080_63372922-4d41-4d81-8d9b-eebaf44acabf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215203
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05744080
Hyphenated Format 0574-4080

Supplemental Identifiers

RxCUI
311381
UNII
YEH1EZ96K6

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 loteprednol etabonate (source: ndc)
Generic Name loteprednol etabonate (source: ndc)
Application Number ANDA215203 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0574-4080-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0574-4080-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

0574-4080-05 1 BOTTLE, DROPPER in 1 CARTON (0574-4080-05) / 5 mL in 1 BOTTLE, DROPPER 0574-4080-10 1 BOTTLE, DROPPER in 1 CARTON (0574-4080-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

loteprednol etabonate (2 mg/mL)

Linked Drug Pages (1)

LOTEPREDNOL ETABONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "63372922-4d41-4d81-8d9b-eebaf44acabf", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["311381"], "spl_set_id": ["63372922-4d41-4d81-8d9b-eebaf44acabf"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0574-4080-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0574-4080-05", "marketing_start_date": "20251215"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0574-4080-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0574-4080-10", "marketing_start_date": "20251215"}], "brand_name": "LOTEPREDNOL ETABONATE", "product_id": "0574-4080_63372922-4d41-4d81-8d9b-eebaf44acabf", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0574-4080", "generic_name": "loteprednol etabonate", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOTEPREDNOL ETABONATE", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "2 mg/mL"}], "application_number": "ANDA215203", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}