TISSEEL

UNIISPL

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338956401
4 mL in 1 SYRINGE, PLASTIC (0338-9564-01)

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": {
    "b3f69e25-1b87-4507-81fa-582ea084673d": {
      "match": "brand_token",
      "title": "TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) KIT TISSEEL FIBRIN SEALANT (FIBRINOGEN HUMAN, HUMAN THROMBIN) SOLUTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "9",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0338-9564_e704d5a7-9db0-4f0f-8267-7ea92d8d882e",
  "productndc": "0338-9564",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
  "proprietary_name": "TISSEEL",
  "active_ingred_unit": "mg/mL; [iU]/mL",
  "application_number": "BLA103980",
  "marketing_category": "BLA",
  "nonproprietary_name": "fibrinogen human, human thrombin",
  "start_marketing_date": "19980501",
  "active_numerator_strength": "86.5; 500"
}

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