NDC 58160-976
Bexsero
Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen
Bexsero is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Neisseria Meningitidis Group B Nhba Fusion Protein Antigen; Neisseria Meningitidis Group B Fhbp Fusion Protein Antigen; Neisseria Meningitidis Group B Nada Protein Antigen; Neisseria Meningitidis Group B Strain Nz98/254 Outer Membrane Vesicle.
| Product ID | 58160-976_43ffa05f-f32d-4606-9a3f-d40f0521a143 |
| NDC | 58160-976 |
| Product Type | Vaccine |
| Proprietary Name | Bexsero |
| Generic Name | Neisseria Meningitidis Serogroup B Nhba Fusion Protein Antigen, Neisseria Meningitidis Serogroup B Fhbp Fusion Protein Antigen And Neisseria Meningitidis Serogroup B Nada Protein Antigen |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2016-12-01 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125546 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN; NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE |
| Active Ingredient Strength | 50 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 58160-976-20
10 SYRINGE in 1 CARTON (58160-976-20) > .5 mL in 1 SYRINGE (58160-976-02)
| Marketing Start Date | 2016-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 58160-976-20 [58160097620]
Bexsero INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125546 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-12-01 |
NDC 58160-976-06 [58160097606]
Bexsero INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125546 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-12-01 |
NDC 58160-976-02 [58160097602]
Bexsero INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125546 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-12-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN | 50 ug/.5mL |
Trademark Results [Bexsero]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BEXSERO 79104116 4130376 Live/Registered |
Glaxosmithkline Biologicals S.A. 2011-09-22 |
 BEXSERO 77896927 3821791 Live/Registered |
GLAXOSMITHKLINE BIOLOGICALS S.A. 2009-12-18 |
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