loteprednol etabonate

Generic: loteprednol etabonate

Labeler: bausch & lomb incorporated
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 incorporated
Dosage Form GEL
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/g

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-508
Product ID 24208-508_0cdbef52-3996-4d79-85ae-c5dd70ac93ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA202872
Listing Expiration 2026-12-31
Marketing Start 2021-02-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208508
Hyphenated Format 24208-508

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 (24208-508-01) / 5 g in 1 BOTTLE
source: ndc

Packages (1)

24208-508-01 1 BOTTLE in 1 CARTON (24208-508-01) / 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": "0cdbef52-3996-4d79-85ae-c5dd70ac93ed", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["1312625"], "spl_set_id": ["7bbdbd31-5a8f-4d69-aa8e-5b700895e804"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (24208-508-01)  / 5 g in 1 BOTTLE", "package_ndc": "24208-508-01", "marketing_start_date": "20210217"}], "brand_name": "Loteprednol Etabonate", "product_id": "24208-508_0cdbef52-3996-4d79-85ae-c5dd70ac93ed", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "24208-508", "generic_name": "loteprednol etabonate", "labeler_name": "Bausch & Lomb Incorporated", "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": "20210217", "listing_expiration_date": "20261231"}