lotemax sm

Generic: loteprednol etabonate

Labeler: bausch & lomb incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lotemax sm
Generic Name loteprednol etabonate
Labeler bausch & lomb incorporated
Dosage Form GEL
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 3.8 mg/g

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-507
Product ID 24208-507_91998c80-00ef-40b9-8316-c95b6e4aa713
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208219
Listing Expiration 2026-12-31
Marketing Start 2019-02-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208507
Hyphenated Format 24208-507

Supplemental Identifiers

RxCUI
2118537 2118539
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 lotemax sm (source: ndc)
Generic Name loteprednol etabonate (source: ndc)
Application Number NDA208219 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3.8 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (24208-507-01) / .5 g in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (24208-507-02) / 5 g in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (24208-507-07) / 5 g in 1 BOTTLE
source: ndc

Packages (3)

24208-507-01 1 BOTTLE in 1 CARTON (24208-507-01) / .5 g in 1 BOTTLE 24208-507-02 1 BOTTLE in 1 CARTON (24208-507-02) / 5 g in 1 BOTTLE 24208-507-07 1 BOTTLE in 1 CARTON (24208-507-07) / 5 g in 1 BOTTLE

Ingredients (1)

loteprednol etabonate (3.8 mg/g)

Linked Drug Pages (1)

Lotemax SM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "91998c80-00ef-40b9-8316-c95b6e4aa713", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["2118537", "2118539"], "spl_set_id": ["6f9477b5-699f-4d3b-b9a6-0cc238266237"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (24208-507-01)  / .5 g in 1 BOTTLE", "package_ndc": "24208-507-01", "marketing_start_date": "20190225"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (24208-507-02)  / 5 g in 1 BOTTLE", "package_ndc": "24208-507-02", "marketing_start_date": "20190225"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (24208-507-07)  / 5 g in 1 BOTTLE", "package_ndc": "24208-507-07", "marketing_start_date": "20190225"}], "brand_name": "Lotemax SM", "product_id": "24208-507_91998c80-00ef-40b9-8316-c95b6e4aa713", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "24208-507", "generic_name": "loteprednol etabonate", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lotemax SM", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "3.8 mg/g"}], "application_number": "NDA208219", "marketing_category": "NDA", "marketing_start_date": "20190225", "listing_expiration_date": "20261231"}