0006-4963 NDC - ZOSTAVAX (ZOSTER VACCINE LIVE)

Drug Information

Product NDC: 0006-4963

Proprietary Name: ZOSTAVAX

Non Proprietary Name: Zoster Vaccine Live

Active Ingredient(s):
  • 19400 [PFU]/.65mL VARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGEN


Administration Route(s): SUBCUTANEOUS

Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

Pharmacy Class(es):
  • Live Attenuated Varicella Zoster Virus Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Vaccines;
  • Attenuated [CS];
  • Chickenpox Vaccine [CS];
  • Live Attenuated Herpes Zoster Virus Vaccine [EPC];
  • Herpes Zoster Vaccine [CS]

Labeler Information

Labeler Name: Merck Sharp & Dohme Corp.
Product Type: VACCINE
FDA Application Number: BLA125123
Marketing Category: BLA
Start Marketing Date:5/25/2006

Package Information

No. Package Code Package Description Billing Unit
10006-4963-001 VIAL, SINGLE-DOSE in 1 CARTON (0006-4963-00) > .65 mL in 1 VIAL, SINGLE-DOSE (0006-4963-01)EA
20006-4963-4110 VIAL, SINGLE-DOSE in 1 CARTON (0006-4963-41) > .65 mL in 1 VIAL, SINGLE-DOSE (0006-4963-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-4963The 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 NAMEVACCINEIndicates 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 NAMEZOSTAVAXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEZoster Vaccine LiveThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, POWDER, LYOPHILIZED, FOR SUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/25/2006This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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 NUMBERBLA125123This 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 NAMEMerck Sharp & Dohme Corp.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVARICELLA-ZOSTER VIRUS STRAIN OKA/MERCK LIVE ANTIGENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH19400 
ACTIVE INGRED UNIT[PFU]/.65mL 
PHARM CLASSESLive Attenuated Varicella Zoster Virus Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [CS],Chickenpox Vaccine [CS],Live Attenuated Herpes Zoster Virus Vaccine [EPC],Herpes Zoster Vaccine [CS] 

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