Data / Drug companies / GlaxoSmithKline Biologicals SA
GlaxoSmithKline Biologicals SA: 25 products in the FDA NDC directory, labeler code 58160
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
GlaxoSmithKline Biologicals SA (labeler code 58160) lists 25 products in the FDA National Drug Code Directory, covering 12 finished drugs by generic name. By type: 25 vaccines. Its main marketing category is biologics (BLA). The newest product started marketing on July 1, 2026.
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- Labeler code
- 58160
- Products in commercial distribution
- 25
- Packages
- 26
- Finished drugs by generic name
- 12
- Prescription products
- 0
- Over the counter products
- 0
- Started marketing in the last 12 months
- 4
- Products with a marketing end date set
- 1
- Earliest marketing start
- February 16, 2007
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Biologics (BLA) | 24 | 96% |
| Other unapproved drugs | 1 | 4% |
Products by type
| Type | Products | Share |
|---|---|---|
| Vaccines | 25 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Respiratory syncytial virus vaccine recombinant, adjuvanted | 3 | 1 |
| Haemophilus b conjugate vaccine (tetanus toxoid conjugate) | 2 | 1 |
| Hepatitis b vaccine (recombinant) | 2 | 4 |
| Zoster vaccine recombinant, adjuvanted | 2 | 2 |
| Hepatitis a vaccine | 2 | 2 |
| Influenza virus vaccine | 1 | 2 |
| Rotavirus vaccine, live, oral | 1 | 1 |
| Influenza a h5 monovalent vaccine | 1 | 1 |
| Meningococcal (groups a, b, c, w and y) | 1 | 1 |
| Measels, mumps, and rubella vaccine, live | 1 | 1 |
| As03 | 1 | 1 |
| Hepatitis a and hepatitis b (recombinant) vaccine | 1 | 2 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Kit | 10 | 40% |
| Injection, suspension | 8 | 32% |
| Injection, solution | 3 | 12% |
| Suspension | 3 | 12% |
| Solution | 1 | 4% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Fluarix 2026/2027 | 58160-725 | Suspension | Biologics (BLA) | July 1, 2026 |
| Arepanrix | 58160-742 | Kit | Biologics (BLA) | May 11, 2026 |
| Arexvy | 58160-894 | Kit | Biologics (BLA) | April 30, 2026 |
| Arexvy | 58160-882 | Kit | Biologics (BLA) | April 30, 2026 |
| Shingrix | 58160-849 | Injection, solution | Biologics (BLA) | July 16, 2025 |
| Penmenvy | 58160-757 | Kit | Biologics (BLA) | February 14, 2025 |
| Hiberix | 58160-726 | Kit | Biologics (BLA) | December 20, 2023 |
| Arexvy | 58160-848 | Kit | Biologics (BLA) | May 3, 2023 |
| Rotarix | 58160-740 | Solution | Biologics (BLA) | February 1, 2023 |
| Menveo | 58160-827 | Injection, solution | Biologics (BLA) | December 9, 2022 |
| Priorix | 58160-824 | Kit | Biologics (BLA) | June 3, 2022 |
| As03 | 58160-855 | Injection, solution | Other unapproved drugs | November 10, 2020 |
| Shingrix | 58160-823 | Kit | Biologics (BLA) | October 20, 2017 |
| Menveo | 58160-955 | Kit | Biologics (BLA) | March 1, 2017 |
| Bexsero | 58160-976 | Injection, suspension | Biologics (BLA) | December 1, 2016 |
| Hiberix | 58160-818 | Kit | Biologics (BLA) | December 21, 2015 |
| Boostrix | 58160-842 | Suspension | Biologics (BLA) | July 24, 2009 |
| Pediarix | 58160-811 | Injection, suspension | Biologics (BLA) | July 24, 2009 |
| Infanrix | 58160-810 | Suspension | Biologics (BLA) | July 24, 2009 |
| Kinrix | 58160-812 | Injection, suspension | Biologics (BLA) | July 9, 2008 |
| Twinrix | 58160-815 | Injection, suspension | Biologics (BLA) | June 7, 2007 |
| Engerix-b | 58160-820 | Injection, suspension | Biologics (BLA) | April 25, 2007 |
| Havrix | 58160-826 | Injection, suspension | Biologics (BLA) | April 13, 2007 |
| Engerix-b | 58160-821 | Injection, suspension | Biologics (BLA) | March 28, 2007 |
| Havrix | 58160-825 | Injection, suspension | Biologics (BLA) | February 16, 2007 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.