Home NDC 58160-827 Menveo
Product NDC 58160-827
11-digit product format 581600827
Labeler code 58160
Product ID 58160-827_ffd9ae2b-caa1-4753-86f2-fc7a8180ff79
Type VACCINE
Nonproprietary name Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler GlaxoSmithKline Biologicals SA
Application BLA125300
Marketing category BLA
Marketing start 2022-12-09
Substance NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN; NEISSERIA MENINGITIDIS GROUP Y CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN
Active strength 10; 5; 5; 5 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 Menveo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEISSERIA MENINGITIDIS GROUP A CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 10 ug/.5mL NEISSERIA MENINGITIDIS GROUP C CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug/.5mL NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug/.5mL NEISSERIA MENINGITIDIS GROUP Y CAPSULAR OLIGOSACCHARIDE DIPHTHERIA CRM197 PROTEIN CONJUGATE ANTIGEN 5 ug/.5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58160-827-03 Menveo 0.5 mL in 1 VIAL INJECTION, SOLUTION 0.5 19 58160-827-30 Menveo 10 in 1 CARTON INJECTION, SOLUTION 10 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58160-827 MENVEO (MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE DIPHTHERIA CRM197 CONJUGATE VACCINE) KIT MENVEO (MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE DIPHTHERIA CRM197 CONJUGATE VACCINE) INJECTION, SOLUTION [GLAXOSMITHKLINE BIOLOGICALS SA] 18 Current NDC, Legacy NDC, 2 package rows 20250406_2dc730d5-55fd-4e98-8c8a-daa7d8f872b0.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125300 Menveo Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 901514 meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (MCV4 generic for Menveo) 0.5 ML Injection PSN 2dc730d5-55fd-4e98-8c8a-daa7d8f872b0 19 901518 MENVEO vaccine 0.5 ML Injection PSN 2dc730d5-55fd-4e98-8c8a-daa7d8f872b0 19 901518 0.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML Injection [Menveo] SBD 2dc730d5-55fd-4e98-8c8a-daa7d8f872b0 19 901514 0.5 ML Neisseria meningitidis serogroup A oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.02 MG/ML / Neisseria meningitidis serogroup C oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup W-135 oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML / Neisseria meningitidis serogroup Y oligosaccharide diphtheria CRM197 protein conjugate vaccine 0.01 MG/ML Injection SCD 2dc730d5-55fd-4e98-8c8a-daa7d8f872b0 19 901514 meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine 0.5 ML Injection SY 2dc730d5-55fd-4e98-8c8a-daa7d8f872b0 19 901518 Menveo Meningococcal (groups A, C, Y and W-135) oligosaccharide Diphtheria CRM197 Conjugate Vaccine 0.5 ML Injection SY 2dc730d5-55fd-4e98-8c8a-daa7d8f872b0 19
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58160-827-03 58160082703 0.5 mL in 1 VIAL 0.5 ml Historical 58160-827-30 58160082730 10 VIAL in 1 CARTON (58160-827-30) / .5 mL in 1 VIAL (58160-827-03) 10 vial 2022-12-09 0000-00-00 No No Current