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  5. NDC Package Code: 76297-002-71 Water

NDC Package 76297-002-71 Water

Solution - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
76297-002-71
Package Description:
40 VIAL in 1 CASE / 15 mL in 1 VIAL
Product Code:
76297-002
Non-Proprietary Name:
Water
Substance Name:
Water
Usage Information:
KOĀTE® is a human plasma-derived antihemophilic factor indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency).Limitation of UseKOĀTE is not indicated for the treatment of von Willebrand disease.
11-Digit NDC Billing Format:
76297000271
NDC to RxNorm Crosswalk:
  • RxCUI: 1718962 - antihemophilic factor, human 1 UNT Injection
  • RxCUI: 1718962 - factor VIII, human 1 UNT Injection
  • RxCUI: 1718970 - Koate-DVI 1 UNT Injection
  • RxCUI: 1718970 - antihemophilic factor, human 1 UNT Injection [Koate]
  • RxCUI: 1718970 - Koate 1 UNT Injection
    • Product Type:
    Drug For Further Processing
    Labeler Name:
    Laboratorios Grifols Sa
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Active Ingredient(s):
  • WATER 1 mL/mL
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    02-04-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    76297-002-0177 VIAL in 1 CASE / 5 mL in 1 VIAL
    76297-002-1177 VIAL in 1 CASE / 10 mL in 1 VIAL
    76297-002-2140 VIAL in 1 CASE / 20 mL in 1 VIAL
    76297-002-3142 VIAL in 1 CASE / 30 mL in 1 VIAL
    76297-002-4130 VIAL in 1 CASE / 40 mL in 1 VIAL
    76297-002-5130 VIAL in 1 CASE / 50 mL in 1 VIAL
    76297-002-6177 VIAL in 1 CASE / 2.5 mL in 1 VIAL

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76297-002-71?

    The NDC Packaged Code 76297-002-71 is assigned to an UNFINISHED drug package of 40 vial in 1 case / 15 ml in 1 vial of Water, drug for further processing labeled by Laboratorios Grifols Sa. The product's dosage form is solution and is administered via form.

    Is NDC 76297-002 included in the NDC Directory?

    Yes, Water is an UNFINISHED PRODUCT with code 76297-002 that is active and included in the NDC Directory. The product was first marketed by Laboratorios Grifols Sa on February 04, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 76297-002-71?

    The 11-digit format is 76297000271. 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 5-3-2 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
    5-3-276297-002-715-4-276297-0002-71