NDC 49281-564

QUADRACEL

Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine

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

Packaging

NDC 49281-564-10

10 VIAL, SINGLE-USE in 1 PACKAGE (49281-564-10) > .5 mL in 1 VIAL, SINGLE-USE (49281-564-58)

• Marketing Start Date: 2015-03-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49281-564-58 [49281056458]

QUADRACEL INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125525
• Product Type: VACCINE
• Marketing Start Date: 2015-03-24

NDC 49281-564-10 [49281056410]

QUADRACEL INJECTION, SUSPENSION

• Marketing Category: BLA
• Application Number: BLA125525
• Product Type: VACCINE
• Marketing Start Date: 2015-03-24

Drug Details

Active Ingredients

Ingredient	Strength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)	15 [Lf]/.5mL

Pharmacological Class

• 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]
• Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
• Actively Acquired Immunity [PE]
• Vaccines
• Inactivated [CS]
• Diphtheria Toxoid [CS]

NDC Crossover Matching brand name "QUADRACEL" or generic name "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine"

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