loteprednol etabonate

Generic: loteprednol etabonate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate
Generic Name loteprednol etabonate
Labeler northstar rxllc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-324
Product ID 72603-324_ed9f004b-f910-4d75-b205-e96b6254946e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212450
Listing Expiration 2026-12-31
Marketing Start 2024-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603324
Hyphenated Format 72603-324

Supplemental Identifiers

RxCUI
311382
UPC
0372603324013
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 (72603-324-01) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72603-324-02) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (72603-324-03) / 15 mL in 1 BOTTLE
source: ndc

Packages (3)

72603-324-01 1 BOTTLE in 1 CARTON (72603-324-01) / 5 mL in 1 BOTTLE 72603-324-02 1 BOTTLE in 1 CARTON (72603-324-02) / 10 mL in 1 BOTTLE 72603-324-03 1 BOTTLE in 1 CARTON (72603-324-03) / 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": "ed9f004b-f910-4d75-b205-e96b6254946e", "openfda": {"upc": ["0372603324013"], "unii": ["YEH1EZ96K6"], "rxcui": ["311382"], "spl_set_id": ["ed9f004b-f910-4d75-b205-e96b6254946e"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-324-01)  / 5 mL in 1 BOTTLE", "package_ndc": "72603-324-01", "marketing_start_date": "20240901"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-324-02)  / 10 mL in 1 BOTTLE", "package_ndc": "72603-324-02", "marketing_start_date": "20240901"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (72603-324-03)  / 15 mL in 1 BOTTLE", "package_ndc": "72603-324-03", "marketing_start_date": "20240901"}], "brand_name": "LOTEPREDNOL ETABONATE", "product_id": "72603-324_ed9f004b-f910-4d75-b205-e96b6254946e", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72603-324", "generic_name": "LOTEPREDNOL ETABONATE", "labeler_name": "NorthStar RxLLC", "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": "20240901", "listing_expiration_date": "20261231"}