Drug Information

Product NDC: 0004-0038

Proprietary Name: Valcyte

Non Proprietary Name: valganciclovir

Active Ingredient(s):

Administration Route(s): ORAL


Pharmacy Class(es):
  • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC];
  • DNA Polymerase Inhibitors [MoA];
  • Nucleoside Analog [EXT];
  • Nucleoside Analog Antiviral [EPC]

Labeler Information

Labeler Name: Genentech, Inc.
FDA Application Number: NDA021304
Marketing Category: NDA
Start Marketing Date:3/29/2001

Package Information

No. Package Code Package Description Billing Unit
10004-0038-221 BOTTLE, PLASTIC in 1 CARTON (0004-0038-22) > 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0004-0038The 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 NAMEValcyteThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEvalganciclovirThe 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 DATE3/29/2001This 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 NUMBERNDA021304This 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 NAMEGenentech, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVALGANCICLOVIR HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESCytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC] 

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This page was last updated on: 7/3/2020