trifluridine

Generic: trifluridine

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name trifluridine
Generic Name trifluridine
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

trifluridine 10 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-044
Product ID 61314-044_d0e32882-06fe-4062-adae-3751ffc9979f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074311
Listing Expiration 2026-12-31
Marketing Start 2001-05-14

Pharmacologic Class

Established (EPC)
nucleoside analog antiviral [epc] nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314044
Hyphenated Format 61314-044

Supplemental Identifiers

RxCUI
313477
UNII
RMW9V5RW38
NUI
N0000175459 N0000175466 N0000175595 N0000000233

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 trifluridine (source: ndc)
Generic Name trifluridine (source: ndc)
Application Number ANDA074311 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (61314-044-75) / 7.5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

61314-044-75 1 BOTTLE, PLASTIC in 1 CARTON (61314-044-75) / 7.5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

trifluridine (10 mg/mL)

Linked Drug Pages (1)

Trifluridine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "d0e32882-06fe-4062-adae-3751ffc9979f", "openfda": {"nui": ["N0000175459", "N0000175466", "N0000175595", "N0000000233"], "unii": ["RMW9V5RW38"], "rxcui": ["313477"], "spl_set_id": ["abc1d07f-91ee-4421-bc9b-457d0ed41f4c"], "pharm_class_epc": ["Nucleoside Analog Antiviral [EPC]", "Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (61314-044-75)  / 7.5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "61314-044-75", "marketing_start_date": "20010514"}], "brand_name": "Trifluridine", "product_id": "61314-044_d0e32882-06fe-4062-adae-3751ffc9979f", "dosage_form": "SOLUTION", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Analog Antiviral [EPC]", "Nucleoside Analog [EXT]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "61314-044", "generic_name": "trifluridine", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Trifluridine", "active_ingredients": [{"name": "TRIFLURIDINE", "strength": "10 mg/mL"}], "application_number": "ANDA074311", "marketing_category": "ANDA", "marketing_start_date": "20010514", "listing_expiration_date": "20261231"}