NDC 49281-225

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED

Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated).

Product ID49281-225_458e947b-5d39-4ae5-b1cf-bbe63f0b0926
NDC49281-225
Product TypeVaccine
Proprietary NameDIPHTHERIA AND TETANUS TOXOIDS ADSORBED
Generic NameCorynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated) And Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated)
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2010-03-29
Marketing CategoryBLA / BLA
Application NumberBLA103944
Labeler NameSanofi Pasteur Inc.
Substance NameCORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient Strength25 [Lf]/.5mL; [Lf]/.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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49281-225-10

10 VIAL in 1 PACKAGE (49281-225-10) > .5 mL in 1 VIAL (49281-225-58)
Marketing Start Date2010-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49281-225-10 [49281022510]

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103944
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-03-29

NDC 49281-225-58 [49281022558]

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103944
Product TypeVACCINE
Billing UnitML
Marketing Start Date2013-07-15

Drug Details

Active Ingredients

IngredientStrength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)25 [Lf]/.5mL

Pharmacological Class

  • 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]

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