Labeler
GlaxoSmithKline Biologicals SA NDC Codes
GlaxoSmithKline Biologicals SA lists 25 finished drug products in the FDA NDC Directory under NDC labeler code 58160.
Overview
Each product below links to its own NDC page with package NDCs in 10- and 11-digit form.
- Drugs
- Arexvy, Shingrix, Hiberix, Menveo, Engerix-B, Havrix, Fluarix 2026/2027, Arepanrix, Penmenvy, Rotarix, Priorix, As03, Bexsero, Infanrix, Pediarix
- Active ingredients
- Clostridium tetani toxoid antigen (Formaldehyde inactivated), Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated), Bordetella pertussis toxoid antigen (Formaldehyde, Glutaraldehyde inactivated), Bordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated), Bordetella pertussis pertactin antigen (Formaldehyde inactivated), Hepatitis b virus subtype adw2 hbsag surface protein antigen, Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated), Poliovirus type 1 antigen (Formaldehyde inactivated), Poliovirus type 2 antigen (Formaldehyde inactivated), Poliovirus type 3 antigen (Formaldehyde inactivated), Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated), Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated)
- NDC labeler codes
- 58160
- Strengths
- Clostridium tetani toxoid antigen (Formaldehyde inactivated) 10 [iU]/.5mL; Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL; Bordetella pertussis toxoid antigen (Formaldehyde, Glutaraldehyde inactivated) 25 ug/.5mL; Bordetella pertussis pertactin antigen (Formaldehyde inactivated) 8 ug/.5mL; Bordetella pertussis filamentous hemagglutinin antigen (Formaldehyde inactivated) 25 ug/.5mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug/.5mL; Poliovirus type 1 antigen (Formaldehyde inactivated) 40 [iU]/.5mL; Poliovirus type 2 antigen (Formaldehyde inactivated) 8 [iU]/.5mL; Poliovirus type 3 antigen (Formaldehyde inactivated) 32 [iU]/.5mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL; Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL; Influenza a virus a/croatia/10136rv/2023 x-425a (H3n2) antigen (Formaldehyde inactivated) 15 ug/.5mL; Influenza b virus b/austria/1359417/2021 bvr-26 antigen (Formaldehyde inactivated) 15 ug/.5mL; Recombinant varicella zoster virus glycoprotein e antigen 50 ug/.5mL; Human rotavirus a type g1p(8) strain rix4414 live antigen 1000 [CCID_50]/mL; 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; Neisseria meningitidis group b nhba fusion protein antigen 50 ug/.5mL
- Dosage forms
- Kit, Injection, Suspension, Suspension, Injection, Solution, Solution
- Routes
- Intramuscular, Oral
- Drug classes (FDA established)
- Inactivated Bordetella Pertussis Vaccine, Inactivated Poliovirus Vaccine, Inactivated Meningococcal Vaccine, Inactivated Clostridium Tetani Vaccine, Inactivated Corynebacterium Diphtheriae Vaccine, Inactivated Hepatitis A Virus Vaccine, Live Attenuated Rotavirus Vaccine
- HCPCS / J-code
- CPT 90750 — Vaccine product code for SHINGRIX (zoster vaccine recombinant, adjuvanted)
- Package NDCs
- 26
NDC codes
Newest listings first. Each row links to the product’s NDC page.
| Product | Strength | Form · route | Product NDC | Package NDCs (11-digit) | HCPCS |
|---|---|---|---|---|---|
| Fluarix 2026/2027influenza virus vaccine | Influenza a virus a/victoria/4897/2022 ivr-238 (H1n1) antigen (Formaldehyde inactivated) 15 ug/.5mL + 2 more ingredients | SuspensionIntramuscular | 58160-725 | 58160-0725-52 | — |
| Arepanrixinfluenza a h5 monovalent vaccine | — | Kit | 58160-742 | 58160-0742-25 | — |
| Arexvyrespiratory syncytial virus vaccine recombinant, adjuvanted | — | Kit | 58160-882 | 58160-0882-12 | — |
| Arexvyrespiratory syncytial virus vaccine recombinant, adjuvanted | — | Kit | 58160-894 | 58160-0894-15 | — |
| Shingrixzoster vaccine recombinant, adjuvanted | Recombinant varicella zoster virus glycoprotein e antigen 50 ug/.5mL | Injection, SolutionIntramuscular | 58160-849 | 58160-0849-52 | — |
| Penmenvymeningococcal (groups a, b, c, w and y) | — | Kit | 58160-757 | 58160-0757-15 | — |
| Hiberixhaemophilus b conjugate vaccine (tetanus toxoid conjugate) | — | Kit | 58160-726 | 58160-0726-15 | — |
| Arexvyrespiratory syncytial virus vaccine recombinant, adjuvanted | — | Kit | 58160-848 | 58160-0848-11 | — |
| Rotarixrotavirus vaccine, live, oral | Human rotavirus a type g1p(8) strain rix4414 live antigen 1000 [CCID_50]/mL | SolutionOral | 58160-740 | 58160-0740-21 | — |
| Menveomeningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine | Neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen 10 ug/.5mL + 3 more ingredients | Injection, SolutionIntramuscular | 58160-827 | 58160-0827-30 | — |
| Priorixmeasels, mumps, and rubella vaccine, live | — | Kit | 58160-824 | 58160-0824-15 | — |
| As03 | — | Injection, SolutionIntramuscular | 58160-855 | 58160-0855-19 | — |
| Shingrixzoster vaccine recombinant, adjuvanted | — | Kit | 58160-823 | 58160-0823-11 | — |
| Menveomeningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine | — | Kit | 58160-955 | 58160-0955-09 | — |
| Bexseroneisseria meningitidis serogroup b nhba fusion protein antigen, neisseria meningitidis serogroup b fhbp fusion protein antigen and neisseria meningitidis serogroup b nada protein antigen | Neisseria meningitidis group b nhba fusion protein antigen 50 ug/.5mL + 3 more ingredients | Injection, SuspensionIntramuscular | 58160-976 | 58160-0976-20 | — |
| Hiberixhaemophilus b conjugate vaccine (tetanus toxoid conjugate) | — | Kit | 58160-818 | 58160-0818-11 | — |
| Infanrixdiphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed | Clostridium tetani toxoid antigen (Formaldehyde inactivated) 10 [iU]/.5mL + 4 more ingredients | SuspensionIntramuscular | 58160-810 | 58160-0810-52 | — |
| Pediarixdiphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b (recombinant) and inactivated poliovirus vaccine combined | Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL + 8 more ingredients | Injection, SuspensionIntramuscular | 58160-811 | 58160-0811-52 | — |
| Boostrixtetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed | Clostridium tetani toxoid antigen (Formaldehyde inactivated) 5 [iU]/.5mL + 4 more ingredients | SuspensionIntramuscular | 58160-842 | 58160-0842-52 | — |
| Kinrixdiphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine | Corynebacterium diphtheriae toxoid antigen (Formaldehyde inactivated) 25 [iU]/.5mL + 7 more ingredients | Injection, SuspensionIntramuscular | 58160-812 | 58160-0812-52 | — |
| Twinrixhepatitis a and hepatitis b (recombinant) vaccine | Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/mL; Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL | Injection, SuspensionIntramuscular | 58160-815 | 58160-0815-52 | — |
| Engerix-Bhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw2 hbsag surface protein antigen 10 ug/.5mL | Injection, SuspensionIntramuscular | 58160-820 | 58160-0820-52 | — |
| Havrixhepatitis a vaccine | Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 1440 [iU]/mL | Injection, SuspensionIntramuscular | 58160-826 | 58160-0826-52 | — |
| Engerix-Bhepatitis b vaccine (recombinant) | Hepatitis b virus subtype adw2 hbsag surface protein antigen 20 ug/mL | Injection, SuspensionIntramuscular | 58160-821 | 58160-0821-1158160-0821-52 | — |
| Havrixhepatitis a vaccine | Hepatitis a virus strain hm175 antigen (Formaldehyde inactivated) 720 [iU]/.5mL | Injection, SuspensionIntramuscular | 58160-825 | 58160-0825-52 | — |
GlaxoSmithKline Biologicals SA: common questions
- What is GlaxoSmithKline Biologicals SA's NDC labeler code?
- 58160. The labeler code is the first segment of each NDC. About labeler codes.
- Is there a J-code for GlaxoSmithKline Biologicals SA?
- Med-Code's HCPCS directory matches CPT 90750 to these products. NDC vs J-code.
- Which NDC goes on a claim?
- The package NDC of what was given, in 11-digit form. How to convert a 10-digit NDC.