loteprednol etabonate

Generic: loteprednol etabonate

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler bausch & lomb americas inc.
Dosage Form GEL
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/g

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-508
Product ID 82260-508_2d5813e8-a1fc-db90-e063-6294a90a6ca7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA202872
Listing Expiration 2026-12-31
Marketing Start 2023-06-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260508
Hyphenated Format 82260-508

Supplemental Identifiers

RxCUI
1312625
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 NDA202872 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (82260-508-01) / 5 g in 1 BOTTLE
source: ndc

Packages (1)

82260-508-01 1 BOTTLE in 1 CARTON (82260-508-01) / 5 g in 1 BOTTLE

Ingredients (1)

loteprednol etabonate (5 mg/g)

Linked Drug Pages (1)

Loteprednol Etabonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2d5813e8-a1fc-db90-e063-6294a90a6ca7", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["1312625"], "spl_set_id": ["cc8638ae-0444-4a8b-bcad-fa946f607b5d"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (82260-508-01)  / 5 g in 1 BOTTLE", "package_ndc": "82260-508-01", "marketing_start_date": "20230630"}], "brand_name": "Loteprednol Etabonate", "product_id": "82260-508_2d5813e8-a1fc-db90-e063-6294a90a6ca7", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82260-508", "generic_name": "loteprednol etabonate", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loteprednol Etabonate", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/g"}], "application_number": "NDA202872", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230630", "listing_expiration_date": "20261231"}