zioptan

Generic: tafluprost

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

Drug Facts

Product Profile

Brand Name zioptan
Generic Name tafluprost
Labeler thea pharma inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tafluprost .015 mg/mL

Manufacturer
Thea Pharma Inc.

Identifiers & Regulatory

Product NDC 82584-609
Product ID 82584-609_4c11a69a-2fb8-368d-e063-6394a90aa09d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202514
Listing Expiration 2027-12-31
Marketing Start 2022-10-28

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc]
Mechanism of Action
prostaglandin receptor agonists [moa]
Chemical Structure
prostaglandins [cs]
Physiologic Effect
increased prostaglandin activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82584609
Hyphenated Format 82584-609

Supplemental Identifiers

RxCUI
1244611 1244616
UNII
1O6WQ6T7G3
NUI
N0000175454 N0000000106 N0000009526 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 zioptan (source: ndc)
Generic Name tafluprost (source: ndc)
Application Number NDA202514 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .015 mg/mL
source: ndc
Packaging
  • 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
source: ndc

Packages (1)

82584-609-30 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

Ingredients (1)

tafluprost (.015 mg/mL)

Linked Drug Pages (1)

ZIOPTAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4c11a69a-2fb8-368d-e063-6394a90aa09d", "openfda": {"nui": ["N0000175454", "N0000000106", "N0000009526", "M0017805"], "unii": ["1O6WQ6T7G3"], "rxcui": ["1244611", "1244616"], "spl_set_id": ["db529b54-2ac7-4020-9791-7333bbe6c90f"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_pe": ["Increased Prostaglandin Activity [PE]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]"], "pharm_class_moa": ["Prostaglandin Receptor Agonists [MoA]"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "82584-609-30", "marketing_start_date": "20221028"}], "brand_name": "ZIOPTAN", "product_id": "82584-609_4c11a69a-2fb8-368d-e063-6394a90aa09d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Increased Prostaglandin Activity [PE]", "Prostaglandin Analog [EPC]", "Prostaglandin Receptor Agonists [MoA]", "Prostaglandins [CS]"], "product_ndc": "82584-609", "generic_name": "Tafluprost", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZIOPTAN", "active_ingredients": [{"name": "TAFLUPROST", "strength": ".015 mg/mL"}], "application_number": "NDA202514", "marketing_category": "NDA", "marketing_start_date": "20221028", "listing_expiration_date": "20271231"}