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 5 mg/mL

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-4135
Product ID 0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215204
Listing Expiration 2027-12-31
Marketing Start 2026-01-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05744135
Hyphenated Format 0574-4135

Supplemental Identifiers

RxCUI
311382
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 ANDA215204 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

0574-4135-05 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-05) / 5 mL in 1 BOTTLE, DROPPER 0574-4135-10 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-10) / 10 mL in 1 BOTTLE, DROPPER 0574-4135-15 1 BOTTLE, DROPPER in 1 CARTON (0574-4135-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

loteprednol etabonate (5 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": "1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["55ec893d-4955-4d2c-8b5b-84f462d23e02"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0574-4135-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "0574-4135-05", "marketing_start_date": "20260112"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0574-4135-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "0574-4135-10", "marketing_start_date": "20260112"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (0574-4135-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "0574-4135-15", "marketing_start_date": "20260112"}], "brand_name": "LOTEPREDNOL ETABONATE", "product_id": "0574-4135_1c88bd5e-7e65-4cfe-b1d9-0894f4a4f82a", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0574-4135", "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": "5 mg/mL"}], "application_number": "ANDA215204", "marketing_category": "ANDA", "marketing_start_date": "20260112", "listing_expiration_date": "20271231"}