Diphtheria And Tetanus Toxoids Adsorbed Injection, Suspension
NDC 49281-225
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Diphtheria And Tetanus Toxoids Adsorbed (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) and clostridium tetani toxoid antigen (formaldehyde inactivated)) is a BLA-approved product labeled by Sanofi Pasteur Inc.. This medication is typically used as a actively acquired immunity [pe]. It is supplied as a white injection, suspension for intramuscular administration. This product entry covers the primary NDC 49281-225 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
49281-225
Proprietary Name:
Diphtheria And Tetanus Toxoids Adsorbed
Non-Proprietary Name: [1]
Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)
Substance Name: [2]
Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection, Suspension
- A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
Intramuscular - Administration within a muscle.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
49281
Product Label ID:
FDA Application Number: [6]
BLA103944
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
03-29-2010
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325 - CLOUDY)
Code Structure Chart
Product Details
What is NDC 49281-225?
The NDC code 49281-225 is assigned by the FDA to the product Diphtheria And Tetanus Toxoids Adsorbed. It is commonly known by its generic name, corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) and clostridium tetani toxoid antigen (formaldehyde inactivated). This pharmaceutical product is labeled by Sanofi Pasteur Inc. and is currently categorized as listed product. The medication is a injection, suspension administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49281-225-10. 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?
Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday).Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated.Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection.
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:
- CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H)
- CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (Active Moiety)
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13)
- CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (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:
- ALUMINUM PHOSPHATE (UNII: F92V3S521O)
- FORMALDEHYDE (UNII: 1HG84L3525)
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: 1244205 - diphtheria toxoid vaccine 25 UNT/ML / tetanus toxoid vaccine (DT) 5 UNT in 0.5 ML Injection
- RxCUI: 1244205 - 0.5 ML diphtheria toxoid vaccine, inactivated 50 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection
- RxCUI: 1244205 - diphtheria toxoid vaccine 25 UNT/ML / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection
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.
- Actively Acquired Immunity - [PE] (Physiologic Effect)
- Actively Acquired Immunity - [PE] (Physiologic Effect)
- Diphtheria Toxoid - [CS]
- Inactivated Clostridium Tetani Vaccine - [EPC] (Established Pharmacologic Class)
- Inactivated Corynebacterium Diphtheriae Vaccine - [EPC] (Established Pharmacologic Class)
- Tetanus Toxoid - [CS]
- Vaccines, Inactivated - [CS]
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Patient Education
Tetanus, Diphtheria (Td) Vaccine
Why get vaccinated? Td vaccine can prevent tetanus and diphtheria. Tetanus enters the body through cuts or wounds. Diphtheria spreads from person to person. TETANUS (T) causes painful stiffening of the muscles. Tetanus can lead to serious health problems, including being unable to open the mouth, having trouble swallowing and breathing, or death. DIPHTHERIA (D) can lead to difficulty breathing, heart failure, paralysis, or death.
[Learn More]
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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".
