Pneumovax 23 Injection, Solution
NDC 0006-4837

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0006-4837?
  4. Pneumovax 23 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Pneumovax 23 (pneumococcal vaccine polyvalent) is a BLA-approved product labeled by Merck Sharp & Dohme Llc. This vaccine helps protect against serious infection (e. It is supplied as a injection, solution for intramuscular; subcutaneous administration. This product entry covers the primary NDC 0006-4837 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0006-4837
Proprietary Name:
Pneumovax 23
Non-Proprietary Name: [1]
Pneumococcal Vaccine Polyvalent
Substance Name: [2]
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
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Merck Sharp & Dohme Llc
Labeler Code:
0006
Product Label ID:
bb362a20-6d91-4ae8-bebb-9ee8b2591814
FDA Application Number: [6]
BLA101094
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
07-21-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0006-4837?

The NDC code 0006-4837 is assigned by the FDA to the product Pneumovax 23. It is commonly known by its generic name, pneumococcal vaccine polyvalent. This pharmaceutical product is labeled by Merck Sharp & Dohme Llc and is currently categorized as listed product. The medication is a injection, solution administered via intramuscular; subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0006-4837-03. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This vaccine helps protect against serious infection (e.g., meningitis, bacteria in the blood) due to certain bacteria (Streptococcus pneumoniae). This vaccine is important for preventing infection in individuals at risk (e.g., those with heart disease, lung disease, liver disease, diabetes, alcoholism, spleen problems, sickle cell anemia, or HIV, or those living in a nursing home).

What are Active Ingredients of 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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: H9NOI61UH1)
  • STREPTOCOCCUS PNEUMONIAE TYPE 1 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: H9NOI61UH1) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: E11P4F3X4S)
  • STREPTOCOCCUS PNEUMONIAE TYPE 2 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: E11P4F3X4S) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 4FVB62AFF1)
  • STREPTOCOCCUS PNEUMONIAE TYPE 3 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 4FVB62AFF1) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: CGS5KI3Q2M)
  • STREPTOCOCCUS PNEUMONIAE TYPE 4 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: CGS5KI3Q2M) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: N8R9GL539D)
  • STREPTOCOCCUS PNEUMONIAE TYPE 5 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: N8R9GL539D) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 57F7254B6Q)
  • STREPTOCOCCUS PNEUMONIAE TYPE 6B CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 57F7254B6Q) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: X1K54R2P9I)
  • STREPTOCOCCUS PNEUMONIAE TYPE 7F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: X1K54R2P9I) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 669818346F)
  • STREPTOCOCCUS PNEUMONIAE TYPE 8 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 669818346F) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 313LJP87ET)
  • STREPTOCOCCUS PNEUMONIAE TYPE 9N CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 313LJP87ET) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: DL82PE6ANE)
  • STREPTOCOCCUS PNEUMONIAE TYPE 9V CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: DL82PE6ANE) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 328VNB72T8)
  • STREPTOCOCCUS PNEUMONIAE TYPE 10A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 328VNB72T8) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: N967BGT6XW)
  • STREPTOCOCCUS PNEUMONIAE TYPE 11A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: N967BGT6XW) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: S46U1CM432)
  • STREPTOCOCCUS PNEUMONIAE TYPE 12F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: S46U1CM432) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: G1GFK9898U)
  • STREPTOCOCCUS PNEUMONIAE TYPE 14 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: G1GFK9898U) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 667Y1EG6EW)
  • STREPTOCOCCUS PNEUMONIAE TYPE 15B CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 667Y1EG6EW) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 3RED79E75R)
  • STREPTOCOCCUS PNEUMONIAE TYPE 17F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 3RED79E75R) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 23036553F6)
  • STREPTOCOCCUS PNEUMONIAE TYPE 18C CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 23036553F6) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 5K0VU709JD)
  • STREPTOCOCCUS PNEUMONIAE TYPE 19F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 5K0VU709JD) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 9W2T4OSF98)
  • STREPTOCOCCUS PNEUMONIAE TYPE 19A CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 9W2T4OSF98) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: V3FC0DK9XS)
  • STREPTOCOCCUS PNEUMONIAE TYPE 20 CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: V3FC0DK9XS) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 7NLV25LOSI)
  • STREPTOCOCCUS PNEUMONIAE TYPE 22F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 7NLV25LOSI) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: PYD255827T)
  • STREPTOCOCCUS PNEUMONIAE TYPE 23F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: PYD255827T) (Active Moiety)
  • STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 2MGG3XW1L2)
  • STREPTOCOCCUS PNEUMONIAE TYPE 33F CAPSULAR POLYSACCHARIDE ANTIGEN (UNII: 2MGG3XW1L2) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1547580 - pneumococcal 23-valent polysaccharide vaccine (PPSV23) 0.5 ML Prefilled Syringe
  • RxCUI: 1547580 - 0.5 ML Streptococcus pneumoniae type 1 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 10A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 11A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 12F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 14 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 15B capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 17F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 18C capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 19A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 19F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 2 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 20 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 22F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 23F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 3 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 33F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 4 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 5 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 6B capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 7F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 8 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 9N capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 9V capsular polysaccharide antigen 0.05 MG/ML Prefilled Syringe
  • RxCUI: 1547580 - pneumococcal vaccine 23-polyvalent 0.5 ML Prefilled Syringe
  • RxCUI: 1547582 - PNEUMOVAX 23 vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 1547582 - 0.5 ML Streptococcus pneumoniae type 1 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 10A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 11A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 12F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 14 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 15B capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 17F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 18C capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 19A capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 19F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 2 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 20 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 22F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 23F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 3 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 33F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 4 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 5 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 6B capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 7F capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 8 capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 9N capsular polysaccharide antigen 0.05 MG/ML / Streptococcus pneumoniae type 9V capsular polysaccharide antigen 0.05 MG/ML Prefilled Syringe [Pneumovax 23]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Pneumococcal Polysaccharide Vaccine


Why get vaccinated? Pneumococcal polysaccharide vaccine (PPSV23) can prevent pneumococcal disease. Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, which is an infection of the lungs. Pneumococcal bacteria are one of the most common causes of pneumonia. Besides pneumonia, pneumococcal bacteria can also cause: Ear infections Sinus infections Meningitis (infection of the tissue covering the brain and spinal cord) Bacteremia (bloodstream infection) Anyone can get pneumococcal disease, but children under 2 years of age, people with certain medical conditions, adults 65 years or older, and cigarette smokers are at the highest risk. Most pneumococcal infections are mild. However, some can result in long-term problems, such as brain damage or hearing loss. Meningitis, bacteremia, and pneumonia caused by pneumococcal disease can be fatal.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? 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.
What kind of product is this? 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? 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.
What is the Marketing Category? 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".