QUADRACEL is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is 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); Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated).
Product ID | 49281-564_3fb496fb-d22a-47b5-9b50-6530bb32094a |
NDC | 49281-564 |
Product Type | Vaccine |
Proprietary Name | QUADRACEL |
Generic Name | Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine |
Dosage Form | Injection, Suspension |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 2015-03-24 |
Marketing Category | BLA / BLA |
Application Number | BLA125525 |
Labeler Name | Sanofi Pasteur Inc. |
Substance Name | 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); POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Active Ingredient Strength | 20 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.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], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [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] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2015-03-24 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125525 |
Product Type | VACCINE |
Marketing Start Date | 2015-03-24 |
Marketing Category | BLA |
Application Number | BLA125525 |
Product Type | VACCINE |
Marketing Start Date | 2015-03-24 |
Ingredient | Strength |
---|---|
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 [Lf]/.5mL |
NDC | Brand Name | Generic Name |
---|---|---|
49281-562 | QUADRACEL | diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine |
49281-564 | QUADRACEL | diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine |
58160-812 | KINRIX | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUADRACEL 90407426 not registered Live/Pending |
Precision Architectural Lighting, Inc. 2020-12-23 |
QUADRACEL 86327927 5237414 Live/Registered |
SANOFI PASTEUR INC. 2014-07-03 |
QUADRACEL 85225589 not registered Dead/Abandoned |
Sanofi Pasteur Limited/ Sanofi Pasteur Limitee 2011-01-25 |
QUADRACEL 77228051 not registered Dead/Abandoned |
Sanofi Pasteur Limited/Sanofi Pasteur Limitee 2007-07-12 |
QUADRACEL 75583409 not registered Dead/Abandoned |
Connaught Technology Corporation 1998-11-05 |
QUADRACEL 74365740 not registered Dead/Abandoned |
AMERICAN CYANAMID COMPANY 1993-03-08 |