Drug Information

Product NDC: 0074-0566

Proprietary Name: Venclexta

Non Proprietary Name: Venetoclax

Active Ingredient(s):
  • 50 mg/1 VENETOCLAX

Administration Route(s): ORAL


Pharmacy Class(es):
  • BCL-2 Inhibitor [EPC];
  • Increased Cellular Death [PE];
  • P-Glycoprotein Inhibitors [MoA]

Labeler Information

Labeler Name: AbbVie Inc.
FDA Application Number: NDA208573
Marketing Category: NDA
Start Marketing Date:4/11/2016

Package Information

No. Package Code Package Description Billing Unit
10074-0566-071 BLISTER PACK in 1 CARTON (0074-0566-07) > 7 TABLET, FILM COATED in 1 BLISTER PACKEA
20074-0566-111 BLISTER PACK in 1 CARTON (0074-0566-11) > 1 TABLET, FILM COATED in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0074-0566The 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 NAMEVenclextaThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEVenetoclaxThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe 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 DATE4/11/2016This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA208573This 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 NAMEAbbVie Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVENETOCLAXThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESBCL-2 Inhibitor [EPC],Increased Cellular Death [PE],P-Glycoprotein Inhibitors [MoA] 

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This page was last updated on: 8/16/2019