loteprednol etabonate

Generic: loteprednol etabonate

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

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler amneal pharmaceuticals ny llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-1362
Product ID 60219-1362_0e87ba50-9918-4733-8ed3-95ce3c772b07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217484
Listing Expiration 2026-12-31
Marketing Start 2025-05-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 602191362
Hyphenated Format 60219-1362

Supplemental Identifiers

RxCUI
311382
UPC
0360219136229 0360219136236
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 ANDA217484 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (60219-1362-1) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (60219-1362-2) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (60219-1362-3) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

60219-1362-1 1 BOTTLE in 1 CARTON (60219-1362-1) / 5 mL in 1 BOTTLE 60219-1362-2 1 BOTTLE in 1 CARTON (60219-1362-2) / 10 mL in 1 BOTTLE 60219-1362-3 1 BOTTLE in 1 CARTON (60219-1362-3) / 15 mL in 1 BOTTLE

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": "0e87ba50-9918-4733-8ed3-95ce3c772b07", "openfda": {"upc": ["0360219136229", "0360219136236"], "unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["e8b50444-fd49-427e-9c1b-f75cb1b62bb6"], "manufacturer_name": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (60219-1362-1)  / 5 mL in 1 BOTTLE", "package_ndc": "60219-1362-1", "marketing_start_date": "20250522"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (60219-1362-2)  / 10 mL in 1 BOTTLE", "package_ndc": "60219-1362-2", "marketing_start_date": "20250522"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (60219-1362-3)  / 15 mL in 1 BOTTLE", "package_ndc": "60219-1362-3", "marketing_start_date": "20250522"}], "brand_name": "LOTEPREDNOL ETABONATE", "product_id": "60219-1362_0e87ba50-9918-4733-8ed3-95ce3c772b07", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "60219-1362", "generic_name": "loteprednol etabonate", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LOTEPREDNOL ETABONATE", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}], "application_number": "ANDA217484", "marketing_category": "ANDA", "marketing_start_date": "20250522", "listing_expiration_date": "20261231"}