iyuzeh

Generic: latanoprost ophthalmic solution 0.005%

Labeler: thea pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name iyuzeh
Generic Name latanoprost ophthalmic solution 0.005%
Labeler thea pharma inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

latanoprost 50 ug/mL

Manufacturer
Thea Pharma Inc.

Identifiers & Regulatory

Product NDC 82584-003
Product ID 82584-003_1e77daf5-a752-172c-e063-6394a90a8a4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216472
Listing Expiration 2026-12-31
Marketing Start 2023-07-14

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc]
Chemical Structure
prostaglandins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82584003
Hyphenated Format 82584-003

Supplemental Identifiers

RxCUI
314072 2642284
UNII
6Z5B6HVF6O
NUI
N0000175454 M0017805

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 iyuzeh (source: ndc)
Generic Name latanoprost ophthalmic solution 0.005% (source: ndc)
Application Number NDA216472 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 50 ug/mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH
source: ndc

Packages (1)

82584-003-30 30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH

Ingredients (1)

latanoprost (50 ug/mL)

Linked Drug Pages (1)

IYUZEH ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1e77daf5-a752-172c-e063-6394a90a8a4d", "openfda": {"nui": ["N0000175454", "M0017805"], "unii": ["6Z5B6HVF6O"], "rxcui": ["314072", "2642284"], "spl_set_id": ["192fc081-cc38-4e83-b779-9592e060b915"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (82584-003-30)  / .2 mL in 1 POUCH", "package_ndc": "82584-003-30", "marketing_start_date": "20230714"}], "brand_name": "IYUZEH", "product_id": "82584-003_1e77daf5-a752-172c-e063-6394a90a8a4d", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "82584-003", "generic_name": "Latanoprost Ophthalmic Solution 0.005%", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IYUZEH", "active_ingredients": [{"name": "LATANOPROST", "strength": "50 ug/mL"}], "application_number": "NDA216472", "marketing_category": "NDA", "marketing_start_date": "20230714", "listing_expiration_date": "20261231"}