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NDC 0338-8701 Tachosil

Thrombin Human And Fibrinogen Patch Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0338-8701?
  5. Tachosil Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
0338-8701
Proprietary Name:
Tachosil
Non-Proprietary Name: [1]
Thrombin Human And Fibrinogen
Substance Name: [2]
Fibrinogen Human; Human Thrombin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Baxter Healthcare Corporation
    Labeler Code:
    0338
    Product Label ID:
    69e05cbe-615e-45af-ad7e-92e3650cafc8
    FDA Application Number: [6]
    BLA125351
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-05-2010
    End Marketing Date: [10]
    02-06-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - ACTIVE SIDE)

    Product Packages

    NDC Code 0338-8701-01

    Package Description: 1 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0338-8701-00) / 1 PATCH in 1 BLISTER PACK (0338-8701-99)

    Product Details

    What is NDC 0338-8701?

    The NDC code 0338-8701 is assigned by the FDA to the product Tachosil which is a human prescription drug product labeled by Baxter Healthcare Corporation. The generic name of Tachosil is thrombin human and fibrinogen. The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 0338-8701-01 1 pouch in 1 carton / 1 blister pack in 1 pouch (0338-8701-00) / 1 patch in 1 blister pack (0338-8701-99). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Tachosil?

    TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.Limitations for Use•TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding.•Not for use in children under one month of age.

    What are Tachosil Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Tachosil UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Tachosil Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Tachosil?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1001591 - fibrinogen / thrombin (human) 3.7 inch x 1.9 inch Medicated Patch
    • RxCUI: 1001591 - fibrinogen, human 337 MG / thrombin, human 123 UNT Medicated Patch
    • RxCUI: 1001591 - fibrinogen, human / thrombin, human 3.7 inch x 1.9 inch Medicated Patch
    • RxCUI: 1001593 - TachoSil 3.7 inch x 1.9 inch Medicated Patch
    • RxCUI: 1001593 - fibrinogen, human 337 MG / thrombin, human 123 UNT Medicated Patch [TachoSil]

    Which are the Pharmacologic Classes for Tachosil?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".