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  5. NDC Package Code: 65862-197-37 Zaleplon

NDC Package 65862-197-37 Zaleplon

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:
65862-197-37
Package Description:
50 kg in 1 DRUM
Product Code:
65862-197
Non-Proprietary Name:
Zaleplon
Substance Name:
Zaleplon
Usage Information:
This medication is used for a short time to treat people who have trouble falling asleep. If you have other sleep problems such as not being able to sleep through the night, this medication may not be right for you. Zaleplon is known as a hypnotic. It works on certain centers in the brain to relax you and help you fall asleep faster.
11-Digit NDC Billing Format:
65862019737
Product Type:
Bulk Ingredient
Labeler Name:
Aurobindo Pharma Limited
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):
  • ZALEPLON 50 kg/50kg
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    01-11-2024
    Listing Expiration Date:
    12-31-2025
    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 65862-197-37?

    The NDC Packaged Code 65862-197-37 is assigned to an UNFINISHED drug package of 50 kg in 1 drum of Zaleplon, a bulk ingredient labeled by Aurobindo Pharma Limited. The product's dosage form is powder and is administered via form.

    Is NDC 65862-197 included in the NDC Directory?

    Yes, Zaleplon is an UNFINISHED PRODUCT with code 65862-197 that is active and included in the NDC Directory. The product was first marketed by Aurobindo Pharma Limited on January 11, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 65862-197-37?

    The 11-digit format is 65862019737. 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
    5-3-265862-197-375-4-265862-0197-37