MenQuadfi

Product NDC
49281-590
11-digit product format
492810590
Labeler code
49281
Product ID
49281-590_faddb625-a9a9-4bcf-829e-033c11d2cc1f
Type
VACCINE
Nonproprietary name
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, and NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sanofi Vaccines US Inc.
Application
BLA125701
Marketing category
BLA
Marketing start
2020-04-23
Substance
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN
Active strength
10; 10; 10; 10 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN10 ug/.5mL
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN10 ug/.5mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN10 ug/.5mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN10 ug/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49281-590-01MenQuadfi1 in 1 CARTONINJECTION, SOLUTION116
49281-590-05MenQuadfi5 in 1 CARTONINJECTION, SOLUTION516
49281-590-10MenQuadfi10 in 1 CARTONINJECTION, SOLUTION1016
49281-590-58MenQuadfi0.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION0.516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-590-10ML - Milliliter49281-5905809b4f3-ebc1-4119-92cf-6d0c4f14b12f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-590MENQUADFI (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN, AND NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) INJECTION, SOLUTION [SANOFI PASTEUR INC.]14Current NDC, Legacy NDC, 4 package rows20250528_ab1c3318-578e-4d0c-a21e-fc6df07e9fb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360583meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine 0.5 ML InjectionPSNab1c3318-578e-4d0c-a21e-fc6df07e9fb716
2360588MenQuadfi vaccine 0.5 ML InjectionPSNab1c3318-578e-4d0c-a21e-fc6df07e9fb716
23605880.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML Injection [Menquadfi]SBDab1c3318-578e-4d0c-a21e-fc6df07e9fb716
23605830.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML InjectionSCDab1c3318-578e-4d0c-a21e-fc6df07e9fb716
2360583meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine 0.5 ML InjectionSYab1c3318-578e-4d0c-a21e-fc6df07e9fb716
2360588MenQuadfi Meningococcal (Groups A,C,Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine 0.5 ML InjectionSYab1c3318-578e-4d0c-a21e-fc6df07e9fb716
2360588MenQuadfi vaccine 0.5 ML InjectionSYab1c3318-578e-4d0c-a21e-fc6df07e9fb716
2360583meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine 0.5 ML InjectionPSN6046583d-f1a5-4620-80bc-03992b6525d02
2360588MenQuadfi vaccine 0.5 ML InjectionPSN6046583d-f1a5-4620-80bc-03992b6525d02
23605880.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML Injection [Menquadfi]SBD6046583d-f1a5-4620-80bc-03992b6525d02
23605830.5 ML Neisseria meningitidis serogroup A capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup W-135 capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup Y capsular polysaccharide tetanus toxoid protein conjugate vaccine 0.02 MG/ML InjectionSCD6046583d-f1a5-4620-80bc-03992b6525d02
2360583meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine 0.5 ML InjectionSY6046583d-f1a5-4620-80bc-03992b6525d02
2360588MenQuadfi Meningococcal (Groups A,C,Y and W-135) Polysaccharide Tetanus Toxoid Conjugate Vaccine 0.5 ML InjectionSY6046583d-f1a5-4620-80bc-03992b6525d02
2360588MenQuadfi vaccine 0.5 ML InjectionSY6046583d-f1a5-4620-80bc-03992b6525d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-590-01492810590011 VIAL, SINGLE-DOSE in 1 CARTON (49281-590-01) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-590-58) 2020-04-23NoNoCurrent
49281-590-05492810590055 VIAL, SINGLE-DOSE in 1 CARTON (49281-590-05) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-590-58) 2020-04-230000-00-00NoNoCurrent
49281-590-104928105901010 VIAL, SINGLE-DOSE in 1 CARTON (49281-590-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-590-58) 2020-04-23NoNoCurrent
49281-590-58492810590580.5 mL in 1 VIAL, SINGLE-DOSE0.5 mlHistorical