United States· US:0338-9639_7d6efeb5-5e06-4fd1-a04f-38af0483b6f2

ARTISS

A medicinal product containing fibrinogen human; human thrombin, registered in United States by Baxter Healthcare Corporation.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedARTISSATC—REGISTER NO.US:0338-9639_7d6efeb5…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FIBRINOGEN HUMAN; HUMAN THROMBIN
Manufacturer
Baxter Healthcare Corporation
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0338963901
    4 mL in 1 SYRINGE, PLASTIC (0338-9639-01)
  • ndc11
    0338-9639-01

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Fibrinogen human; human thrombin in 4 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All fibrinogen human; human thrombin products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/2114ae81-58f0-4b77-9ccb-c023cc6c310a
GET /v1/drugs/2114ae81-58f0-4b77-9ccb-c023cc6c310a?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "TOPICAL",
  "source": "ndc",
  "strength": "86.5; 4",
  "substance": "FIBRINOGEN HUMAN; HUMAN THROMBIN",
  "productndc": "0338-9639",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL; [iU]/mL",
  "application_number": "BLA125266",
  "marketing_category": "BLA"
}

See everything about fibrinogen human; human thrombin.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.