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United States · US · US:61953-0020_28f64c1d-b52d-4df0-b976-fe9c0cdd4170

VISTASEAL

UNIISPL

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

Identification

ManufacturerGRIFOLS USA, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6195300201
    1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-1) / 2 mL in 1 SYRINGE, GLASS (61953-0020-2)
  • ndc11
    6195300203
    1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-3) / 4 mL in 1 SYRINGE, GLASS (61953-0020-4)
  • ndc11
    6195300205
    1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-5) / 6 mL in 1 SYRINGE, GLASS (61953-0020-6)
  • ndc11
    6195300207
    1 SYRINGE, GLASS in 1 PACKAGE, COMBINATION (61953-0020-7) / 10 mL in 1 SYRINGE, GLASS (61953-0020-8)

Annotations

UNII (FDA Substance ID)
N94833051K
FIBRINOGEN HUMAN
RxCUI 2264108
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N94833051K",
    "rxcui": "2264108",
    "inchikey": null,
    "display_name": "FIBRINOGEN HUMAN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "a8708417-2f74-4dfa-b6f9-ef88f902e0fc": {
      "match": "brand_token",
      "title": "VISTASEAL (HUMAN FIBRINOGEN, HUMAN THROMBIN) KIT [GRIFOLS USA, LLC]",
      "spl_version": "14",
      "published_date": "2025-09-29"
    }
  },
  "productid": "61953-0020_28f64c1d-b52d-4df0-b976-fe9c0cdd4170",
  "productndc": "61953-0020",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
  "proprietary_name": "VISTASEAL",
  "active_ingred_unit": "mg/mL; [iU]/mL",
  "application_number": "BLA125640",
  "marketing_category": "BLA",
  "nonproprietary_name": "Human fibrinogen, human thrombin",
  "start_marketing_date": "20191101",
  "active_numerator_strength": "80; 500"
}

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