ENGERIX-B

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlaxoSmithKline Biologicals SA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5816082111
10 VIAL in 1 CARTON (58160-821-11) / 1 mL in 1 VIAL (58160-821-01)
ndc11
5816082152
10 SYRINGE in 1 CARTON (58160-821-52) / 1 mL in 1 SYRINGE (58160-821-43)

Annotations

UNII (FDA Substance ID)

9GCJ1L5D1P

HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN

RxCUI 1427171

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9GCJ1L5D1P",
    "rxcui": "1427171",
    "inchikey": null,
    "display_name": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "2ec65f7e-4aa2-4b41-b578-885ea59d6e9d": {
      "match": "brand_token",
      "title": "ENGERIX-B (HEPATITIS B VACCINE (RECOMBINANT)) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "34",
      "published_date": "2026-05-27"
    }
  },
  "productid": "58160-821_6aa9718e-caf6-4427-8051-f2e5438a0386",
  "productndc": "58160-821",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN",
  "proprietary_name": "ENGERIX-B",
  "active_ingred_unit": "ug/mL",
  "application_number": "BLA103239",
  "marketing_category": "BLA",
  "nonproprietary_name": "Hepatitis B Vaccine (Recombinant)",
  "start_marketing_date": "20070328",
  "active_numerator_strength": "20"
}

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