Menactra

Product NDC
49281-589
11-digit product format
492810589
Labeler code
49281
Product ID
49281-589_271ed59c-a374-4fc0-bb92-d13fbdabdeef
Type
VACCINE
Nonproprietary 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
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sanofi Vaccines US Inc.
Application
BLA125089
Marketing category
BLA
Marketing start
2005-01-14
Substance
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
Active strength
4; 4; 4; 4 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Menactra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN4 ug/.5mL
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN4 ug/.5mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN4 ug/.5mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN4 ug/.5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-589-05Menactra5 in 1 PACKAGEINJECTION, SOLUTION515
49281-589-58Menactra0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-589-05ML - Milliliter49281-58991662f5b-fc98-46d0-9922-fe3505e3a30412013-02-13
49281-589-58ML - Milliliter49281-5894d99b8d8-85b9-40e5-856d-4b3c6c07f1b712015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE INGREDIENTRE9A0H8OABMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE INGREDIENT2J57K2523TMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE INGREDIENTZ6R9D1D3KJMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE INGREDIENTMI340WV90BMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE MOIETYRE9A0H8OABMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE MOIETY2J57K2523TMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE MOIETYZ6R9D1D3KJMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGENACTIVE MOIETYMI340WV90BMENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6
formaldehydeINACTIVE INGREDIENT1HG84L3525MENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-589MENACTRA (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) INJECTION, SOLUTION [SANOFI PASTEUR INC.]13Current NDC, Legacy NDC, 2 package rows20230111_4d8781ff-9366-462c-8161-6e958f44fcb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797641Menactra vaccine 0.5 ML InjectionPSN4d8781ff-9366-462c-8161-6e958f44fcb415
797638meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV4 generic for Menactra) 0.5 ML InjectionPSN4d8781ff-9366-462c-8161-6e958f44fcb415
7976410.5 ML Neisseria meningitidis serogroup A capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML Injection [Menactra]SBD4d8781ff-9366-462c-8161-6e958f44fcb415
7976380.5 ML Neisseria meningitidis serogroup A capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide diphtheria toxoid protein conjugate vaccine 0.104 MG/ML InjectionSCD4d8781ff-9366-462c-8161-6e958f44fcb415
797641Menactra Meningococcal (Groups A,C,Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 ML InjectionSY4d8781ff-9366-462c-8161-6e958f44fcb415
797638meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine 0.5 ML InjectionSY4d8781ff-9366-462c-8161-6e958f44fcb415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-589-05492810589055 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-589-05) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-589-58) 2005-01-140000-00-00NoNoCurrent
49281-589-58492810589580.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical