United States· US:58160-821_6aa9718e-caf6-4427-8051-f2e5438a0386
ENGERIX-B
A medicinal product containing hepatitis b virus subtype adw2 hbsag surface protein antigen, registered in United States by GlaxoSmithKline Biologicals SA.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN
- Manufacturer
- GlaxoSmithKline Biologicals SA
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 9, 2026
Packs & prices · 4
- ndc1158160-821-11
- ndc1158160-821-52
- ndc11581608211110 VIAL in 1 CARTON (58160-821-11) / 1 mL in 1 VIAL (58160-821-01)
- ndc11581608215210 SYRINGE in 1 CARTON (58160-821-52) / 1 mL in 1 SYRINGE (58160-821-43)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/ff66aefc-2d12-4f12-a873-03707b004f2d GET /v1/drugs/ff66aefc-2d12-4f12-a873-03707b004f2d?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "INTRAMUSCULAR",
"source": "ndc",
"strength": "20",
"substance": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
"productndc": "58160-821",
"dosage_form": "INJECTION, SUSPENSION",
"dea_schedule": null,
"strength_unit": "ug/mL",
"application_number": "BLA103239",
"marketing_category": "BLA"
}See everything about hepatitis b virus subtype adw2 hbsag surface protein antigen.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.