loteprednol etabonate

Generic: loteprednol etabonate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler sun pharmaceutical industries, inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-232
Product ID 62756-232_19d17bf3-2231-4af9-b1da-ca74f015b72d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212450
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756232
Hyphenated Format 62756-232

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 ANDA212450 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (62756-232-90) / 5 mL in 1 BOTTLE
source: ndc

Packages (3)

62756-232-55 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLE 62756-232-56 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLE 62756-232-90 1 BOTTLE in 1 CARTON (62756-232-90) / 5 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": "19d17bf3-2231-4af9-b1da-ca74f015b72d", "openfda": {"unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["36cfd5b8-c892-44e1-aaed-fb32d7aeca7c"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (62756-232-55)  / 10 mL in 1 BOTTLE", "package_ndc": "62756-232-55", "marketing_start_date": "20210501"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62756-232-56)  / 15 mL in 1 BOTTLE", "package_ndc": "62756-232-56", "marketing_start_date": "20210501"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (62756-232-90)  / 5 mL in 1 BOTTLE", "package_ndc": "62756-232-90", "marketing_start_date": "20210501"}], "brand_name": "Loteprednol Etabonate", "product_id": "62756-232_19d17bf3-2231-4af9-b1da-ca74f015b72d", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62756-232", "generic_name": "Loteprednol Etabonate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loteprednol Etabonate", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}], "application_number": "ANDA212450", "marketing_category": "ANDA", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}