loteprednol etabonate

Generic: loteprednol etabonate

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler oceanside pharmaceuticals
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-299
Product ID 68682-299_3246bcdf-e795-46ef-b613-612c0105b693
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA020583
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682299
Hyphenated Format 68682-299

Supplemental Identifiers

RxCUI
311382
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 NDA020583 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68682-299-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68682-299-10) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (68682-299-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

68682-299-05 1 BOTTLE in 1 CARTON (68682-299-05) / 5 mL in 1 BOTTLE 68682-299-10 1 BOTTLE in 1 CARTON (68682-299-10) / 10 mL in 1 BOTTLE 68682-299-15 1 BOTTLE in 1 CARTON (68682-299-15) / 15 mL in 1 BOTTLE

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": "3246bcdf-e795-46ef-b613-612c0105b693", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["f9edfd73-e1b1-44e4-8e7c-90b0c2fa204d"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68682-299-05)  / 5 mL in 1 BOTTLE", "package_ndc": "68682-299-05", "marketing_start_date": "20190701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68682-299-10)  / 10 mL in 1 BOTTLE", "package_ndc": "68682-299-10", "marketing_start_date": "20190701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (68682-299-15)  / 15 mL in 1 BOTTLE", "package_ndc": "68682-299-15", "marketing_start_date": "20190701"}], "brand_name": "Loteprednol Etabonate", "product_id": "68682-299_3246bcdf-e795-46ef-b613-612c0105b693", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68682-299", "generic_name": "loteprednol etabonate", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loteprednol Etabonate", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}], "application_number": "NDA020583", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}