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United States · US · US:71655-103_867ea1a9-2710-483d-a9ef-5b1d6a579f3b

Raxibacumab

UNIISPLATC J06BC02

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

Identification

ManufacturerEmergent Manufacturing Operations Baltimore LLC
CountryUS (United States)
ATC codeJ06BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7165510301
    1 VIAL, SINGLE-USE in 1 CARTON (71655-103-01) / 34 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
794PGL549S
RAXIBACUMAB
RxCUI 1366567
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "794PGL549S",
    "rxcui": "1366567",
    "inchikey": null,
    "display_name": "RAXIBACUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f6927e91-bb46-47b3-ab66-f9d8a9d7b12a": {
      "match": "brand_token",
      "title": "RAXIBACUMAB INJECTION [EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC]",
      "spl_version": "4",
      "published_date": "2026-04-14"
    }
  },
  "productid": "71655-103_867ea1a9-2710-483d-a9ef-5b1d6a579f3b",
  "productndc": "71655-103",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RAXIBACUMAB",
  "proprietary_name": "Raxibacumab",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA125349",
  "marketing_category": "BLA",
  "nonproprietary_name": "raxibacumab",
  "start_marketing_date": "20121214",
  "active_numerator_strength": "50"
}

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