CroFab

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
5063311012
2 VIAL, GLASS in 1 CARTON (50633-110-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11)

Annotations

UNII (FDA Substance ID)

IA6O0K772M

AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE)

RxCUI 885183

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IA6O0K772M",
    "rxcui": "885183",
    "inchikey": null,
    "display_name": "AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE)",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "77abd784-3387-420d-abdc-4fe97215d233": {
      "match": "brand_token",
      "title": "CROFAB (OVINE CROTALIDAE VENOMS IMMUNE FAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BTG INTERNATIONAL INC.]",
      "spl_version": "21",
      "published_date": "2026-06-01"
    }
  },
  "productid": "50633-110_4f536edd-c976-31e5-e063-6294a90a2a08",
  "productndc": "50633-110",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE); CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE); CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE)",
  "proprietary_name": "CroFab",
  "active_ingred_unit": "g/1; g/1; g/1; g/1",
  "application_number": "BLA103788",
  "marketing_category": "BLA",
  "nonproprietary_name": "ovine crotalidae venoms immune fab",
  "start_marketing_date": "20001002",
  "active_numerator_strength": "1; 1; 1; 1"
}

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