loteprednol etabonate

Generic: loteprednol etabonate

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

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler lupin pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70748-300
Product ID 70748-300_822adc09-88c3-41fa-922a-66dfa7e412b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215719
Listing Expiration 2027-12-31
Marketing Start 2025-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70748300
Hyphenated Format 70748-300

Supplemental Identifiers

RxCUI
311382
UPC
0370748300039
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 ANDA215719 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70748-300-01) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (70748-300-02) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

70748-300-01 1 BOTTLE in 1 CARTON (70748-300-01) / 5 mL in 1 BOTTLE 70748-300-02 1 BOTTLE in 1 CARTON (70748-300-02) / 10 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": "822adc09-88c3-41fa-922a-66dfa7e412b2", "openfda": {"upc": ["0370748300039"], "unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["1a506712-b032-463a-9a17-480558445808"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-300-01)  / 5 mL in 1 BOTTLE", "package_ndc": "70748-300-01", "marketing_start_date": "20250715"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (70748-300-02)  / 10 mL in 1 BOTTLE", "package_ndc": "70748-300-02", "marketing_start_date": "20250827"}], "brand_name": "loteprednol etabonate", "product_id": "70748-300_822adc09-88c3-41fa-922a-66dfa7e412b2", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "70748-300", "generic_name": "loteprednol etabonate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "loteprednol etabonate", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}], "application_number": "ANDA215719", "marketing_category": "ANDA", "marketing_start_date": "20250715", "listing_expiration_date": "20271231"}