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 SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 2 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-361
Product ID 82260-361_4a467df9-02df-061f-e063-6294a90a3beb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020803
Listing Expiration 2027-12-31
Marketing Start 2024-02-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260361
Hyphenated Format 82260-361

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 NDA020803 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-361-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

82260-361-05 1 BOTTLE, DROPPER in 1 CARTON (82260-361-05) / 5 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": "4a467df9-02df-061f-e063-6294a90a3beb", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["311381"], "spl_set_id": ["7714824b-29ed-442a-ad2d-13ee2fc6bc42"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-361-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-361-05", "marketing_start_date": "20240209"}], "brand_name": "loteprednol etabonate", "product_id": "82260-361_4a467df9-02df-061f-e063-6294a90a3beb", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82260-361", "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": "2 mg/mL"}], "application_number": "NDA020803", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240209", "listing_expiration_date": "20271231"}