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 CAPSULE
Routes
ORAL
Active Ingredients

enzalutamide 40 mg/1

Manufacturer
Astellas Pharma US, Inc.

Identifiers & Regulatory

Product NDC 0469-1125
Product ID 0469-1125_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203415
Listing Expiration 2026-12-31
Marketing Start 2012-08-31

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 04691125
Hyphenated Format 0469-1125

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 NDA203415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 56 CAPSULE in 1 BLISTER PACK (0469-1125-56)
source: ndc

Packages (1)

0469-1125-56 56 CAPSULE in 1 BLISTER PACK (0469-1125-56)

Ingredients (1)

enzalutamide (40 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": true, "description": "56 CAPSULE in 1 BLISTER PACK (0469-1125-56)", "package_ndc": "0469-1125-56", "marketing_start_date": "20120831"}], "brand_name": "Xtandi", "product_id": "0469-1125_cfc2fbc2-2657-407f-b0f0-bd41fb98d89e", "dosage_form": "CAPSULE", "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": "0469-1125", "generic_name": "enzalutamide", "labeler_name": "Astellas Pharma US, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xtandi", "active_ingredients": [{"name": "ENZALUTAMIDE", "strength": "40 mg/1"}], "application_number": "NDA203415", "marketing_category": "NDA", "marketing_start_date": "20120831", "listing_expiration_date": "20261231"}