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United States · US · US:58160-818_6321e15a-da1f-42a3-b3ac-82611b5c9d7f

Hiberix

SPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGlaxoSmithKline Biologicals SA
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5816081811
    1 KIT in 1 CARTON (58160-818-11) * 10 VIAL in 1 CARTON (58160-816-05) / .5 mL in 1 VIAL (58160-816-01) * 10 VIAL in 1 PACKAGE (58160-817-05) / .85 mL in 1 VIAL (58160-817-01)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "745ff8df-1618-4b76-9aa1-6f42752c0dda": {
      "match": "brand_token",
      "title": "HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "22",
      "published_date": "2026-01-06"
    }
  },
  "productid": "58160-818_6321e15a-da1f-42a3-b3ac-82611b5c9d7f",
  "productndc": "58160-818",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": null,
  "proprietary_name": "Hiberix",
  "active_ingred_unit": null,
  "application_number": "BLA125347",
  "marketing_category": "BLA",
  "nonproprietary_name": "Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)",
  "start_marketing_date": "20151221",
  "active_numerator_strength": null
}

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