NDC product

Adacel TDaP

NDC 49281-400 · Sanofi Vaccines US Inc.

Key facts

Product NDC 49281-400
Proprietary name Adacel
Nonproprietary name CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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
Substances CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler Sanofi Vaccines US Inc.
Product type VACCINE
Marketing category BLA
Application number BLA125111
Pharmacologic classes Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Pertussis Vaccine [CS] and 3 more
Marketing start Jun 10, 2005
Listing certified through Dec 31, 2027

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Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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