| Product NDC: | 49281-589 |
| Proprietary Name: | Menactra |
| Non Proprietary Name: | NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN |
| Active Ingredient(s): | 4; 4; 4; 4 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL & nbsp; NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 49281-589 |
| Labeler Name: | Sanofi Pasteur Inc. |
| Product Type: | VACCINE |
| FDA Application Number: | BLA125089 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20050114 |
| Package NDC: | 49281-589-05 |
| Package Description: | 5 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-589-05) > .5 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 49281-589-05 |
| Proprietary Name | Menactra |
| Package Description | 5 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-589-05) > .5 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 49281-589 |
| Product Type Name | VACCINE |
| Non Proprietary Name | NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20050114 |
| Marketing Category Name | BLA |
| Labeler Name | Sanofi Pasteur Inc. |
| Substance Name | NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN |
| Strength Number | 4; 4; 4; 4 |
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| Pharmaceutical Classes | Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Meningococcal Vaccine [EPC],Actively Acquired Immunity [PE],Meningococcal Vaccines [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient] |