xtandi

Generic: enzalutamide

Labeler: astellas pharma us, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xtandi
Generic Name enzalutamide
Labeler astellas pharma us, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

enzalutamide 80 mg/1

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-0725
Product ID 0469-0725_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213674
Listing Expiration 2026-12-31
Marketing Start 2020-08-04

Pharmacologic Class

Established (EPC)
androgen receptor inhibitor [epc]
Mechanism of Action
androgen receptor antagonists [moa] cytochrome p450 3a4 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2c19 inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04690725
Hyphenated Format 0469-0725

Supplemental Identifiers

RxCUI
1307303 1307309 2390644 2390646 2390648 2390650
UPC
0304690725602 0304690125990
UNII
93T0T9GKNU
NUI
N0000175560 N0000000243 N0000185506 N0000185507 N0000185607

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 xtandi (source: ndc)
Generic Name enzalutamide (source: ndc)
Application Number NDA213674 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0469-0725-60) / 60 TABLET in 1 BOTTLE
source: ndc

Packages (1)

0469-0725-60 1 BOTTLE in 1 CARTON (0469-0725-60) / 60 TABLET in 1 BOTTLE

Ingredients (1)

enzalutamide (80 mg/1)

Linked Drug Pages (1)

Xtandi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cfc2fbc2-2657-407f-b0f0-bd41fb98d89e", "openfda": {"nui": ["N0000175560", "N0000000243", "N0000185506", "N0000185507", "N0000185607"], "upc": ["0304690725602", "0304690125990"], "unii": ["93T0T9GKNU"], "rxcui": ["1307303", "1307309", "2390644", "2390646", "2390648", "2390650"], "spl_set_id": ["b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]"], "manufacturer_name": ["Astellas Pharma US, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0469-0725-60)  / 60 TABLET in 1 BOTTLE", "package_ndc": "0469-0725-60", "marketing_start_date": "20200804"}], "brand_name": "Xtandi", "product_id": "0469-0725_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]"], "product_ndc": "0469-0725", "generic_name": "enzalutamide", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xtandi", "active_ingredients": [{"name": "ENZALUTAMIDE", "strength": "80 mg/1"}], "application_number": "NDA213674", "marketing_category": "NDA", "marketing_start_date": "20200804", "listing_expiration_date": "20261231"}