NDC 50090-1079

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

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

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 is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by A-s Medication Solutions. The primary component is 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.

Product ID50090-1079_a0761c6c-cbff-4131-af89-259bfb594d57
NDC50090-1079
Product TypeVaccine
Proprietary NameCLOSTRIDIUM 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
Generic NameClostridium 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
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2005-06-10
Marketing CategoryBLA / BLA
Application NumberBLA125111
Labeler NameA-S Medication Solutions
Substance NameCLOSTRIDIUM 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
Active Ingredient Strength5 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharm ClassesInactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria 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]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 50090-1079-0

10 VIAL in 1 PACKAGE (50090-1079-0) > .5 mL in 1 VIAL (50090-1079-9)
Marketing Start Date2005-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-1079-9 [50090107909]

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TO INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Marketing Start Date2005-06-10

NDC 50090-1079-0 [50090107900]

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), BORDETELLA PERTUSSIS TO INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2005-06-10
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [Lf]/.5mL

Pharmacological Class

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

NDC Crossover Matching brand 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" or generic 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"

NDCBrand NameGeneric Name
50090-1079CLOSTRIDIUM 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 ANTIGENCLOSTRIDIUM 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
49281-400AdacelCLOSTRIDIUM 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

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