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United States · US · US:0006-4897_19d4c656-416f-4499-857b-dcc7bed8ccb6

PedvaxHIB

UNIISPL

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

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0006489700
    10 VIAL, SINGLE-DOSE in 1 CARTON (0006-4897-00) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01)

Annotations

UNII (FDA Substance ID)
LUY6P8763W
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "LUY6P8763W",
    "rxcui": null,
    "inchikey": null,
    "display_name": "HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "9dff46c6-4b15-4d10-aca6-d5ef3735a530": {
      "match": "brand_token",
      "title": "PEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]",
      "spl_version": "19",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0006-4897_19d4c656-416f-4499-857b-dcc7bed8ccb6",
  "productndc": "0006-4897",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN",
  "proprietary_name": "PedvaxHIB",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "BLA103237",
  "marketing_category": "BLA",
  "nonproprietary_name": "Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)",
  "start_marketing_date": "19891220",
  "active_numerator_strength": "7.5"
}

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