eulexin

Generic: flutamide

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name eulexin
Generic Name flutamide
Labeler waylis therapeutics llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

flutamide 125 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-143
Product ID 80725-143_497f8d4c-3d59-43d3-93ee-6bdbc391b457
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075298
Listing Expiration 2026-12-31
Marketing Start 2021-11-12

Pharmacologic Class

Established (EPC)
androgen receptor inhibitor [epc]
Mechanism of Action
androgen receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725143
Hyphenated Format 80725-143

Supplemental Identifiers

RxCUI
197726 205646
UPC
0380725143184
UNII
76W6J0943E
NUI
N0000000243 N0000175560

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 eulexin (source: ndc)
Generic Name flutamide (source: ndc)
Application Number ANDA075298 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

80725-143-18 1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

flutamide (125 mg/1)

Linked Drug Pages (1)

Eulexin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "497f8d4c-3d59-43d3-93ee-6bdbc391b457", "openfda": {"nui": ["N0000000243", "N0000175560"], "upc": ["0380725143184"], "unii": ["76W6J0943E"], "rxcui": ["197726", "205646"], "spl_set_id": ["0a905e25-42b6-4937-a689-f01a8f22e644"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (80725-143-18)  / 180 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "80725-143-18", "marketing_start_date": "20211112"}], "brand_name": "Eulexin", "product_id": "80725-143_497f8d4c-3d59-43d3-93ee-6bdbc391b457", "dosage_form": "CAPSULE", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "80725-143", "generic_name": "Flutamide", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Eulexin", "active_ingredients": [{"name": "FLUTAMIDE", "strength": "125 mg/1"}], "application_number": "ANDA075298", "marketing_category": "ANDA", "marketing_start_date": "20211112", "listing_expiration_date": "20261231"}