loteprednol etabonate

Generic: loteprednol etabonate

Labeler: armas pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler armas pharmaceuticals inc.
Dosage Form GEL
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/g

Manufacturer
ARMAS PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 72485-630
Product ID 72485-630_0919fa30-ff66-f021-e063-6394a90ae4bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212080
Listing Expiration 2026-12-31
Marketing Start 2023-10-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485630
Hyphenated Format 72485-630

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 ANDA212080 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-630-05) / 5 g in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

72485-630-05 1 BOTTLE, DROPPER in 1 CARTON (72485-630-05) / 5 g in 1 BOTTLE, DROPPER

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": "0919fa30-ff66-f021-e063-6394a90ae4bb", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["1312625"], "spl_set_id": ["091a068f-f9b0-b02b-e063-6294a90a95e6"], "manufacturer_name": ["ARMAS PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-630-05)  / 5 g in 1 BOTTLE, DROPPER", "package_ndc": "72485-630-05", "marketing_start_date": "20231025"}], "brand_name": "Loteprednol Etabonate", "product_id": "72485-630_0919fa30-ff66-f021-e063-6394a90ae4bb", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72485-630", "generic_name": "Loteprednol Etabonate", "labeler_name": "ARMAS PHARMACEUTICALS INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loteprednol Etabonate", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/g"}], "application_number": "ANDA212080", "marketing_category": "ANDA", "marketing_start_date": "20231025", "listing_expiration_date": "20261231"}