IYUZEH

Orange BookUNIISPLATC S01EE01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerThea Pharma Inc.

CountryUS (United States)

ATC codeS01EE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8258400330
30 POUCH in 1 CARTON (82584-003-30) / .2 mL in 1 POUCH

Annotations

UNII (FDA Substance ID)

6Z5B6HVF6O

LATANOPROST

RxCUI 43611

Orange Book

N216472

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6Z5B6HVF6O",
    "rxcui": "43611",
    "inchikey": "GGXICVAJURFBLW-CEYXHVGTSA-N",
    "display_name": "LATANOPROST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "192fc081-cc38-4e83-b779-9592e060b915": {
      "match": "brand_token",
      "title": "IYUZEH (LATANOPROST OPHTHALMIC SOLUTION 0.005%) SOLUTION/ DROPS [THEA PHARMA INC.]",
      "spl_version": "7",
      "published_date": "2024-07-31"
    }
  },
  "productid": "82584-003_1e77daf5-a752-172c-e063-6394a90a8a4d",
  "productndc": "82584-003",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "216472",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.005%",
        "product_no": "001",
        "approval_date": "Dec 13, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LATANOPROST",
  "proprietary_name": "IYUZEH",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA216472",
  "marketing_category": "NDA",
  "nonproprietary_name": "Latanoprost Ophthalmic Solution 0.005%",
  "start_marketing_date": "20230714",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code S01EE01.

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