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 5 mg/mL

Manufacturer
ARMAS PHARMACEUTICALS INC.

Identifiers & Regulatory

Product NDC 72485-665
Product ID 72485-665_08a09440-b505-b2c9-e063-6394a90a0d76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207609
Listing Expiration 2026-12-31
Marketing Start 2023-10-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485665
Hyphenated Format 72485-665

Supplemental Identifiers

RxCUI
311382
UPC
0372485665105 0372485665150 0372485665051
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 ANDA207609 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-665-10) / 10 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (72485-665-15) / 15 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (3)

72485-665-05 1 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPER 72485-665-10 1 BOTTLE, DROPPER in 1 CARTON (72485-665-10) / 10 mL in 1 BOTTLE, DROPPER 72485-665-15 1 BOTTLE, DROPPER in 1 CARTON (72485-665-15) / 15 mL in 1 BOTTLE, DROPPER

Ingredients (1)

loteprednol etabonate (5 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": "08a09440-b505-b2c9-e063-6394a90a0d76", "openfda": {"upc": ["0372485665105", "0372485665150", "0372485665051"], "unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["08a091a8-748f-acc4-e063-6394a90af4bc"], "manufacturer_name": ["ARMAS PHARMACEUTICALS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-665-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-665-05", "marketing_start_date": "20231026"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-665-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-665-10", "marketing_start_date": "20231026"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (72485-665-15)  / 15 mL in 1 BOTTLE, DROPPER", "package_ndc": "72485-665-15", "marketing_start_date": "20231026"}], "brand_name": "Loteprednol Etabonate", "product_id": "72485-665_08a09440-b505-b2c9-e063-6394a90a0d76", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72485-665", "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/mL"}], "application_number": "ANDA207609", "marketing_category": "ANDA", "marketing_start_date": "20231026", "listing_expiration_date": "20261231"}