lotemax

Generic: loteprednol etabonate

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

Drug Facts

Product Profile

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

loteprednol etabonate 5 mg/g

Manufacturer
Bausch & Lomb Incorporated

Identifiers & Regulatory

Product NDC 24208-443
Product ID 24208-443_b1d6fda8-73c9-478f-addd-14949e0454e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200738
Listing Expiration 2026-12-31
Marketing Start 2011-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24208443
Hyphenated Format 24208-443

Supplemental Identifiers

RxCUI
1099500 1099503
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 (source: ndc)
Generic Name loteprednol etabonate (source: ndc)
Application Number NDA200738 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (24208-443-01) / 1 g in 1 TUBE
  • 1 TUBE in 1 CARTON (24208-443-35) / 3.5 g in 1 TUBE
source: ndc

Packages (2)

24208-443-01 1 TUBE in 1 CARTON (24208-443-01) / 1 g in 1 TUBE 24208-443-35 1 TUBE in 1 CARTON (24208-443-35) / 3.5 g in 1 TUBE

Ingredients (1)

loteprednol etabonate (5 mg/g)

Linked Drug Pages (1)

Lotemax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b1d6fda8-73c9-478f-addd-14949e0454e4", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["1099500", "1099503"], "spl_set_id": ["902a3c6b-2625-44ec-a077-926e012b3176"], "manufacturer_name": ["Bausch & Lomb Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 TUBE in 1 CARTON (24208-443-01)  / 1 g in 1 TUBE", "package_ndc": "24208-443-01", "marketing_start_date": "20110415"}, {"sample": false, "description": "1 TUBE in 1 CARTON (24208-443-35)  / 3.5 g in 1 TUBE", "package_ndc": "24208-443-35", "marketing_start_date": "20110415"}], "brand_name": "Lotemax", "product_id": "24208-443_b1d6fda8-73c9-478f-addd-14949e0454e4", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "24208-443", "generic_name": "loteprednol etabonate", "labeler_name": "Bausch & Lomb Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lotemax", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/g"}], "application_number": "NDA200738", "marketing_category": "NDA", "marketing_start_date": "20110415", "listing_expiration_date": "20261231"}