0006-4837 NDC - PNEUMOVAX 23 (PNEUMOCOCCAL VACCINE POLYVALENT)

Drug Information

Product NDC: 0006-4837

Proprietary Name: PNEUMOVAX 23

Non Proprietary Name: pneumococcal vaccine polyvalent

Active Ingredient(s):
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN;
  • 25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN


Administration Route(s): INTRAMUSCULAR; SUBCUTANEOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Vaccines;
  • Inactivated [CS];
  • Pneumococcal Vaccines [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Pneumococcal Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pneumococcal Vaccines [CS];
  • Vaccines;
  • Inactivated [CS]

Labeler Information

Labeler Name: Merck Sharp & Dohme Corp.
Product Type: VACCINE
FDA Application Number: BLA101094
Marketing Category: BLA
Start Marketing Date:7/21/2014

Package Information

No. Package Code Package Description Billing Unit
10006-4837-0310 SYRINGE, GLASS in 1 CARTON (0006-4837-03) > .5 mL in 1 SYRINGE, GLASS (0006-4837-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-4837The 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 NAMEPNEUMOVAX 23The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEpneumococcal vaccine polyvalentThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULAR; SUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/21/2014This 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 NUMBERBLA101094This 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 NAMESTREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25 
ACTIVE INGRED UNITug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 
PHARM CLASSESInactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Vaccines, Inactivated [CS],Pneumococcal Vaccines [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Pneumococcal Vaccine [EPC],Actively Acquired Immunity [PE],Pneumococcal Vaccines [CS],Vaccines, Inactivated [CS] 

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This page was last updated on: 1/24/2020