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  5. NDC Package Code: 46438-0038-1 Amitriptyline Hydrochloride

NDC Package 46438-0038-1 Amitriptyline Hydrochloride

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

Table of Contents

    1. Package Information
    2. 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:
46438-0038-1
Package Description:
50 kg in 1 DRUM
Product Code:
46438-0038
Non-Proprietary Name:
Amitriptyline Hydrochloride
Substance Name:
Amitriptyline Hydrochloride
11-Digit NDC Billing Format:
46438003801
Product Type:
Bulk Ingredient
Labeler Name:
Dipharma Francis Srl
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • AMITRIPTYLINE HYDROCHLORIDE 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    01-07-1980
    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.

    Frequently Asked Questions

    What is NDC 46438-0038-1?

    The NDC Packaged Code 46438-0038-1 is assigned to an UNFINISHED drug package of 50 kg in 1 drum of Amitriptyline Hydrochloride, a bulk ingredient labeled by Dipharma Francis Srl. The product's dosage form is powder and is administered via form.

    Is NDC 46438-0038 included in the NDC Directory?

    Yes, Amitriptyline Hydrochloride is an UNFINISHED PRODUCT with code 46438-0038 that is active and included in the NDC Directory. The product was first marketed by Dipharma Francis Srl on January 07, 1980 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 46438-0038-1?

    The 11-digit format is 46438003801. 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 5-4-1 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
    5-4-146438-0038-15-4-246438-0038-01