49281-589 NDC - MENACTRA (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)

Drug Information

  • 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 ug/.5mL NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; 4 ug/.5mL NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; 4 ug/.5mL NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN; 4 ug/.5mL NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN
  • Administration Route(s): INTRAMUSCULAR
  • Dosage Form(s): INJECTION, SOLUTION
  • Pharmacy Class(es): Actively Acquired Immunity [PE]; Actively Acquired Immunity [PE]; Actively Acquired Immunity [PE]; Actively Acquired Immunity [PE]; Inactivated Meningococcal Vaccine [EPC]; Inactivated Meningococcal Vaccine [EPC]; Inactivated Meningococcal Vaccine [EPC]; Inactivated Meningococcal Vaccine [EPC]; Meningococcal Vaccines [CS]; Meningococcal Vaccines [CS]; Meningococcal Vaccines [CS]; Meningococcal Vaccines [CS]; Vaccines; Inactivated [CS]; Vaccines; Inactivated [CS]; Vaccines; Inactivated [CS]; Vaccines; Inactivated [CS]

Labeler Information

Field Name Field Value
Labeler Name: Sanofi Pasteur Inc.
Product Type: VACCINE
FDA Application Number: BLA125089
Marketing Category: BLA
Start Marketing Date:1/14/2005

Package Information

No. Package Code Package Description Billing Unit
149281-589-055 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-589-05) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-589-58)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC49281-589The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEVACCINEIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEMenactraThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMENEISSERIA 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 ANTIGENThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/14/2005This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERBLA125089This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMESanofi Pasteur Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMENEISSERIA 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 ANTIGENAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH4; 4; 4; 4 
ACTIVE INGRED UNITug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL 
PHARM CLASSESActively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Inactivated Meningococcal Vaccine [EPC], Inactivated Meningococcal Vaccine [EPC], Inactivated Meningococcal Vaccine [EPC], Inactivated Meningococcal Vaccine [EPC], Meningococcal Vaccines [CS], Meningococcal Vaccines [CS], Meningococcal Vaccines [CS], Meningococcal Vaccines [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS] 

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This page was last updated on: 12/19/2025

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