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 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 19A CAPSULAR POLYSACCHARIDE ANTIGEN;
25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN;
25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 2 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 3 CAPSULAR POLYSACCHARIDE ANTIGEN;
25 ug/.5mL STREPTOCOCCUS PNEUMONIAE TYPE 33F 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

Administration Route(s): INTRAMUSCULAR; SUBCUTANEOUS

Dosage Form(s): INJECTION, SOLUTION

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];
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];
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];
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;
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];
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:	BLA101094
Marketing Category:	BLA
Start Marketing Date:	7/21/2014

Package Information

No.	Package Code	Package Description	Billing Unit
1	0006-4837-03	10 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 NDC	0006-4837	The 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 NAME	VACCINE	Indicates 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 NAME	PNEUMOVAX 23	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	pneumococcal vaccine polyvalent	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	INJECTION, SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	INTRAMUSCULAR; SUBCUTANEOUS	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	7/21/2014	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	BLA	Product 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 NUMBER	BLA101094	This 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 NAME	Merck Sharp & Dohme LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	STREPTOCOCCUS PNEUMONIAE TYPE 1 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 19A CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 2 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 3 CAPSULAR POLYSACCHARIDE ANTIGEN; STREPTOCOCCUS PNEUMONIAE TYPE 33F 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	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 STRENGTH	25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25; 25
ACTIVE INGRED UNIT	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; ug/.5mL
PHARM CLASSES	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], 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], 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], 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, 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], 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: 2/1/2023

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