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 SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 2 mg/mL

Manufacturer
ARMAS PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 72485-653
Product ID 72485-653_1a784c5a-bdb4-c5b8-e063-6394a90a8f9c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215933
Listing Expiration 2026-12-31
Marketing Start 2023-10-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485653
Hyphenated Format 72485-653

Supplemental Identifiers

RxCUI
311381
UPC
0372485653058 0372485653102
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 ANDA215933 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-653-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

72485-653-05 1 BOTTLE, DROPPER in 1 CARTON (72485-653-05) / 5 mL in 1 BOTTLE, DROPPER 72485-653-10 1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 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": "1a784c5a-bdb4-c5b8-e063-6394a90a8f9c", "openfda": {"upc": ["0372485653058", "0372485653102"], "unii": ["YEH1EZ96K6"], "rxcui": ["311381"], "spl_set_id": ["36c05fa4-6562-4af8-86ac-e79003ee65dd"], "manufacturer_name": ["ARMAS PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-653-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-653-05", "marketing_start_date": "20231024"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-653-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-653-10", "marketing_start_date": "20231024"}], "brand_name": "Loteprednol Etabonate", "product_id": "72485-653_1a784c5a-bdb4-c5b8-e063-6394a90a8f9c", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72485-653", "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": "2 mg/mL"}], "application_number": "ANDA215933", "marketing_category": "ANDA", "marketing_start_date": "20231024", "listing_expiration_date": "20261231"}