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  5. NDC Package Code: 0338-8701-01 Tachosil

NDC Package 0338-8701-01 Tachosil

Thrombin Human And Fibrinogen Patch Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package 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 Code:
0338-8701
Proprietary Name:
Tachosil
Non-Proprietary Name:
Thrombin Human And Fibrinogen
Substance Name:
Fibrinogen Human; Human Thrombin
Usage Information:
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.
11-Digit NDC Billing Format:
00338870101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Baxter Healthcare Corporation
    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):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Active Ingredient(s):
  • FIBRINOGEN HUMAN 5.5 mg/1
  • HUMAN THROMBIN 2 [USP'U]/1
    • Pharmacologic Class(es):
  • Blood Coagulation Factors - [CS]
  • Blood Coagulation Factors - [CS]
  • Human Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Activity - [PE] (Physiologic Effect)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA125351
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    04-05-2010
    End Marketing Date:
    02-06-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0338-8701-01?

    The NDC Packaged Code 0338-8701-01 is assigned to a package of 1 pouch in 1 carton / 1 blister pack in 1 pouch (0338-8701-00) / 1 patch in 1 blister pack (0338-8701-99) of Tachosil, a human prescription drug labeled by Baxter Healthcare Corporation. The product's dosage form is patch and is administered via topical form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 0338-8701 included in the NDC Directory?

    Yes, Tachosil with product code 0338-8701 is active and included in the NDC Directory. The product was first marketed by Baxter Healthcare Corporation on April 05, 2010.

    What is the NDC billing unit for package 0338-8701-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0338-8701-01?

    The 11-digit format is 00338870101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20338-8701-015-4-200338-8701-01