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United States · US · US:82584-609_50281dbf-7a22-69dc-e063-6294a90a2cb9

ZIOPTAN

Orange BookUNIISPLATC S01EE05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerThea Pharma Inc.
CountryUS (United States)
ATC codeS01EE05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8258460930
    3 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
1O6WQ6T7G3
TAFLUPROST
RxCUI 1244607
Orange Book
N202514
AT
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "1O6WQ6T7G3",
    "rxcui": "1244607",
    "inchikey": "WSNODXPBBALQOF-VEJSHDCNSA-N",
    "display_name": "TAFLUPROST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "db529b54-2ac7-4020-9791-7333bbe6c90f": {
      "match": "brand_token",
      "title": "ZIOPTAN (TAFLUPROST) SOLUTION/ DROPS [THEA PHARMA INC.]",
      "spl_version": "7",
      "published_date": "2026-05-06"
    }
  },
  "productid": "82584-609_50281dbf-7a22-69dc-e063-6294a90a2cb9",
  "productndc": "82584-609",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "202514",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.0015%",
        "product_no": "001",
        "approval_date": "Feb 10, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TAFLUPROST",
  "proprietary_name": "ZIOPTAN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA202514",
  "marketing_category": "NDA",
  "nonproprietary_name": "Tafluprost",
  "start_marketing_date": "20221028",
  "active_numerator_strength": ".015"
}

Related drugs

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