49281-562 NDC - QUADRACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE)

Drug Information

Product NDC: 49281-562

Proprietary Name: QUADRACEL

Non Proprietary Name: diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine

Active Ingredient(s):
  • 15 [Lf]/.5mL CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED);
  • 5 [Lf]/.5mL CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED);
  • 20 ug/.5mL BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED);
  • 20 ug/.5mL BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED);
  • 3 ug/.5mL BORDETELLA PERTUSSIS PERTACTIN ANTIGEN;
  • 5 ug/.5mL BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN;
  • 40 [D'ag'U]/.5mL POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED);
  • 8 [D'ag'U]/.5mL POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED);
  • 32 [D'ag'U]/.5mL POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)


Administration Route(s): INTRAMUSCULAR

Dosage Form(s): INJECTION, SUSPENSION

Pharmacy Class(es):
  • Inactivated Corynebacterium Diphtheriae Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Vaccines;
  • Inactivated [CS];
  • Diphtheria Toxoid [CS];
  • Inactivated Clostridium Tetani Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Vaccines;
  • Inactivated [CS];
  • Tetanus Toxoid [CS];
  • Inactivated Bordetella Pertussis Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Pertussis Vaccine [CS];
  • Vaccines;
  • Inactivated [CS];
  • Pertussis Vaccine [CS];
  • Inactivated Bordetella Pertussis Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Bordetella Pertussis Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Vaccines;
  • Inactivated [CS];
  • Pertussis Vaccine [CS];
  • Inactivated Poliovirus Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Poliovirus Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Poliovirus Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Poliovirus Vaccines [CS];
  • Vaccines;
  • Inactivated [CS];
  • Inactivated Poliovirus Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Poliovirus Vaccines [CS];
  • Vaccines;
  • Inactivated [CS]

Labeler Information

Labeler Name: Sanofi Pasteur Inc.
Product Type: VACCINE
FDA Application Number: BLA125525
Marketing Category: BLA
Start Marketing Date:3/24/2015

Package Information

No. Package Code Package Description Billing Unit
149281-562-1010 VIAL, SINGLE-USE in 1 PACKAGE (49281-562-10) > .5 mL in 1 VIAL, SINGLE-USE (49281-562-58)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC49281-562The 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 NAMEQUADRACELThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdiphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccineThe 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 DATE3/24/2015This 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 NUMBERBLA125525This 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 NAMESanofi Pasteur Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECORYNEBACTERIUM 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; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH15; 5; 20; 20; 3; 5; 40; 8; 32 
ACTIVE INGRED UNIT[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL 
PHARM CLASSESInactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS] 

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This page was last updated on: 10/4/2019