tafluprost

Generic: tafluprost opthalmic

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tafluprost
Generic Name tafluprost opthalmic
Labeler micro labs limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

tafluprost .0045 mg/.3mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-264
Product ID 42571-264_4c55f162-175b-d458-e063-6394a90a066f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209051
Listing Expiration 2027-12-31
Marketing Start 2022-11-18

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 42571264
Hyphenated Format 42571-264

Supplemental Identifiers

RxCUI
1244611
UPC
0342571264734 0342571264932
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 tafluprost (source: ndc)
Generic Name tafluprost opthalmic (source: ndc)
Application Number ANDA209051 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .0045 mg/.3mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (42571-264-26) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL
  • 2 POUCH in 1 CARTON (42571-264-73) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL
  • 6 POUCH in 1 CARTON (42571-264-74) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL
source: ndc

Packages (3)

42571-264-26 1 POUCH in 1 CARTON (42571-264-26) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL 42571-264-73 2 POUCH in 1 CARTON (42571-264-73) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL 42571-264-74 6 POUCH in 1 CARTON (42571-264-74) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL

Ingredients (1)

tafluprost (.0045 mg/.3mL)

Linked Drug Pages (1)

tafluprost ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "4c55f162-175b-d458-e063-6394a90a066f", "openfda": {"nui": ["N0000175454", "N0000000106", "N0000009526", "M0017805"], "upc": ["0342571264734", "0342571264932"], "unii": ["1O6WQ6T7G3"], "rxcui": ["1244611"], "spl_set_id": ["fcaab8b3-3791-49ba-909e-a09651a30b33"], "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": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (42571-264-26)  / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL", "package_ndc": "42571-264-26", "marketing_start_date": "20221118"}, {"sample": false, "description": "2 POUCH in 1 CARTON (42571-264-73)  / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL", "package_ndc": "42571-264-73", "marketing_start_date": "20221118"}, {"sample": false, "description": "6 POUCH in 1 CARTON (42571-264-74)  / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL", "package_ndc": "42571-264-74", "marketing_start_date": "20221118"}], "brand_name": "tafluprost", "product_id": "42571-264_4c55f162-175b-d458-e063-6394a90a066f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Increased Prostaglandin Activity [PE]", "Prostaglandin Analog [EPC]", "Prostaglandin Receptor Agonists [MoA]", "Prostaglandins [CS]"], "product_ndc": "42571-264", "generic_name": "tafluprost opthalmic", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tafluprost", "active_ingredients": [{"name": "TAFLUPROST", "strength": ".0045 mg/.3mL"}], "application_number": "ANDA209051", "marketing_category": "ANDA", "marketing_start_date": "20221118", "listing_expiration_date": "20271231"}