Daptacel Injection, Suspension
NDC 49281-286

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 49281-286?
  5. Daptacel Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Daptacel (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen) is a BLA-approved product labeled by Sanofi Vaccines Us 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 49281-286 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
49281-286
Proprietary Name:
Daptacel
Non-Proprietary Name: [1]
Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated), Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated), Bordetella Pertussis Pertactin Antigen, And Bordetella Pertussis Fimbriae 2/3 Antigen
Substance Name: [2]
Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Fimbriae 2/3 Antigen; Bordetella Pertussis Pertactin Antigen; Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated); 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]
Sanofi Vaccines Us Inc.
Labeler Code:
49281
Product Label ID:
06f34d0f-4e72-41d3-967f-8abf3f2005c1
FDA Application Number: [6]
BLA103666
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
05-14-2002
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)

Code Structure Chart

Product Details

What is NDC 49281-286?

The NDC code 49281-286 is assigned by the FDA to the product Daptacel. It is commonly known by its generic name, corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen. This pharmaceutical product is labeled by Sanofi Vaccines Us 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 3 different package configurations. The associated package NDC(s) include: 49281-286-01, 49281-286-05, 49281-286-10. 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?

DAPTACEL® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).

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)
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37)
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37) (Active Moiety)
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY)
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (Active Moiety)
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X)
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X) (Active Moiety)
  • BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A)
  • BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A) (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: 1300308 - DTaP (generic for Daptacel) 0.5 ML Injection
  • RxCUI: 1300308 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.01 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.02 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Injection
  • RxCUI: 1300308 - Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 5 MCG / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 5 MCG / Bordetella pertussis pertactin vaccine, inactivated 3 MCG / Bordetella pertussis toxoid vaccine, inactivated 10 MCG / diphtheria toxoid vaccine 15 UNT / tetanus toxoid vaccine 5 UNT per 0.5 ML Injection
  • RxCUI: 1300308 - diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP generic for Daptacel) 0.5 ML Injection
  • RxCUI: 1300308 - DTaP (diphtheria toxoid vaccine, inactivated 15 UNT / tetanus toxoid vaccine, inactivated 5 UNT / acellular pertussis vaccine, inactivated 23 MCG) per 0.5 ML Injection

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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".