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Drug Information

Product NDC: 0469-1125

Proprietary Name: Xtandi

Non Proprietary Name: enzalutamide

Active Ingredient(s):
  • 40 mg/1 ENZALUTAMIDE

Administration Route(s): ORAL

Dosage Form(s): CAPSULE

Pharmacy Class(es):
  • Androgen Receptor Antagonists [MoA];
  • Androgen Receptor Inhibitor [EPC];
  • Cytochrome P450 2C19 Inducers [MoA];
  • Cytochrome P450 2C9 Inducers [MoA];
  • Cytochrome P450 3A4 Inducers [MoA]

Labeler Information

Labeler Name: Astellas Pharma US, Inc.
FDA Application Number: NDA203415
Marketing Category: NDA
Start Marketing Date:8/31/2012

Package Information

No. Package Code Package Description Billing Unit
10469-1125-5656 CAPSULE in 1 BLISTER PACK (0469-1125-56)

NDC Record

Field Name Field Value Definition
PRODUCT NDC0469-1125The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEXtandiThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEenzalutamideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/31/2012This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at under Structured Product Labeling Resources.
APPLICATION NUMBERNDA203415This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEAstellas Pharma US, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEENZALUTAMIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESAndrogen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA] 

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This page was last updated on: 2/1/2023