0006-4329 NDC - VAXNEUVANCE (PNEUMOCOCCAL 15-VALENT CONJUGATE VACCINE CRM197 PROTEIN ADSORBED)

Drug Information

Product NDC: 0006-4329

Proprietary Name: VAXNEUVANCE

Non Proprietary Name: Pneumococcal 15-valent Conjugate Vaccine CRM197 Protein adsorbed

Active Ingredient(s):
  • 30 ug/.5mL CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 4 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN;
  • 2 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN


Administration Route(s): INTRAMUSCULAR

Dosage Form(s): INJECTION, SUSPENSION

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

Labeler Information

Labeler Name: Merck Sharp & Dohme LLC
Product Type: VACCINE
FDA Application Number: BLA125741
Marketing Category: BLA
Start Marketing Date:7/16/2021

Package Information

No. Package Code Package Description Billing Unit
10006-4329-021 SYRINGE, GLASS in 1 CARTON (0006-4329-02) > .5 mL in 1 SYRINGE, GLASS (0006-4329-01)ML
20006-4329-0310 SYRINGE, GLASS in 1 CARTON (0006-4329-03) > .5 mL in 1 SYRINGE, GLASS (0006-4329-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-4329The 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 NAMEVAXNEUVANCEThe 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 15-valent Conjugate Vaccine CRM197 Protein adsorbedThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/16/2021This 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 NUMBERBLA125741This 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 LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN; STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6A CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGENThe following is the list of active ingredients in this product. An 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 STRENGTH30; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 2; 4; 2; 2 
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 
PHARM CLASSESActively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Inactivated Pneumococcal Vaccine [EPC], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Pneumococcal Vaccines [CS], Vaccines, Conjugate [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS] 

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This page was last updated on: 9/15/2022