DigiFab

UNIISPL

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

Identification

ManufacturerBTG International Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5063312011
1 VIAL, GLASS in 1 CARTON (50633-120-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-120-12)

Annotations

UNII (FDA Substance ID)

YB12NQZ1YN

OVINE DIGOXIN IMMUNE FAB

RxCUI 1745257

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YB12NQZ1YN",
    "rxcui": "1745257",
    "inchikey": null,
    "display_name": "OVINE DIGOXIN IMMUNE FAB",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "49ee0505-77a0-1ff4-e063-6294a90a410e": {
      "match": "brand_token",
      "title": "DIGIFAB (OVINE DIGOXIN IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SALVAGENIX INC.]",
      "spl_version": "4",
      "published_date": "2026-04-14"
    }
  },
  "productid": "50633-120_617e1370-a75c-4d9e-8465-41abfe26025d",
  "productndc": "50633-120",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "OVINE DIGOXIN IMMUNE FAB",
  "proprietary_name": "DigiFab",
  "active_ingred_unit": "mg/1",
  "application_number": "BLA103910",
  "marketing_category": "BLA",
  "nonproprietary_name": "ovine digoxin immune fab",
  "start_marketing_date": "20010831",
  "active_numerator_strength": "40"
}

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