Home NDC 0005-0100 Trumenba
Product NDC 0005-0100
11-digit product format 000050100
Labeler code 0005
Product ID 0005-0100_81783d36-a13f-4075-9962-8f45a9859b97
Type VACCINE
Nonproprietary name meningococcal group B vaccine
Dosage form INJECTION, SUSPENSION
Route INTRAMUSCULAR
Labeler Wyeth Pharmaceutical Division of Wyeth Holdings LLC
Application BLA125549
Marketing category BLA
Marketing start 2014-11-05
Substance NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN; NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN
Active strength 60; 60 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 Trumenba
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN 60 ug/.5mL NEISSERIA MENINGITIDIS GROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN 60 ug/.5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0005-0100-01 Trumenba 0.5 mL in 1 SYRINGE INJECTION, SUSPENSION 0.5 23 0005-0100-05 Trumenba 5 in 1 CARTON INJECTION, SUSPENSION 5 23 0005-0100-10 Trumenba 10 in 1 CARTON INJECTION, SUSPENSION 10 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN ACTIVE INGREDIENT 583WCD0IZI TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN ACTIVE INGREDIENT 7MBD4K530D TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 A05 PROTEIN VARIANT ANTIGEN ACTIVE MOIETY 583WCD0IZI TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LP2086 B01 PROTEIN VARIANT ANTIGEN ACTIVE MOIETY 7MBD4K530D TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 ALUMINUM PHOSPHATE INACTIVE INGREDIENT F92V3S521O TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 HISTIDINE INACTIVE INGREDIENT 4QD397987E TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS CORPORATION, A SUBSIDIARY OF PFIZER INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0005-0100 TRUMENBA (MENINGOCOCCAL GROUP B VACCINE) INJECTION, SUSPENSION [WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS LLC] 22 Current NDC, Legacy NDC, 3 package rows 20250315_bcaf5f75-caaf-41fd-875b-5800310070d1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0005-0100-01 00005010001 0.5 mL in 1 SYRINGE 0.5 ml Historical 0005-0100-02 00005010002 1 SYRINGE in 1 CARTON (0005-0100-02) > .5 mL in 1 SYRINGE (0005-0100-01) 1 syringe 2014-11-05 0000-00-00 No No Current 0005-0100-05 00005010005 5 SYRINGE in 1 CARTON (0005-0100-05) / .5 mL in 1 SYRINGE (0005-0100-01) 5 syringe 2014-11-05 0000-00-00 No No Current 0005-0100-10 00005010010 10 SYRINGE in 1 CARTON (0005-0100-10) / .5 mL in 1 SYRINGE (0005-0100-01) 10 syringe 2014-11-05 0000-00-00 No No Current