42052-1901 NDC - ENZALUTAMIDE SDD HOV A

Drug Information

  • Product NDC: 42052-1901
  • Proprietary Name:
  • Non Proprietary Name: Enzalutamide SDD Hov A
  • Active Ingredient(s): .2 kg/kg ENZALUTAMIDE
  • Administration Route(s):
  • Dosage Form(s): POWDER

Labeler Information

Field Name Field Value
Labeler Name: Hovione LLC
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:7/1/2024

Package Information

No. Package Code Package Description Billing Unit
142052-1901-115 kg in 1 DRUM (42052-1901-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC42052-1901Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT TYPE NAMEDRUG FOR FURTHER PROCESSINGIndicates 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.
NON PROPRIETARY NAMEEnzalutamide SDD Hov AThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMEPOWDERProduct 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 www.fda.gov/edrls under Structured Product Labeling Resources.
START MARKETING DATE7/1/2024This 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.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGProduct 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 www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEHovione LLCName 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.
ACTIVE NUMERATOR STRENGTH.2 
ACTIVE INGRED UNITkg/kg 

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This page was last updated on: 3/6/2026

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