1. Home
  2. Labeler Index
  3. Swati Spentose Private Limited
  4. 52119-021
  5. NDC Package Code: 52119-021-05 Melatonin

NDC Package 52119-021-05 Melatonin

Powder - 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:
52119-021-05
Package Description:
5 kg in 1 DRUM
Product Code:
52119-021
Non-Proprietary Name:
Melatonin
Substance Name:
Melatonin
Usage Information:
Melatonin has been used for short-term treatment of trouble sleeping (insomnia) due to sleep cycle disorders and time changes ("jet lag"). This product may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer time. Melatonin is a substance that your body normally makes. It is thought to help your body's regular daily cycle, hormone production, and sleep patterns. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
11-Digit NDC Billing Format:
52119002105
Product Type:
Bulk Ingredient
Labeler Name:
Swati Spentose Private 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):
  • MELATONIN 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:
    07-01-2019
    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
    52119-021-011 kg in 1 DRUM
    52119-021-022 kg in 1 DRUM
    52119-021-1010 kg in 1 DRUM
    52119-021-1515 kg in 1 DRUM
    52119-021-2020 kg in 1 DRUM
    52119-021-2525 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 52119-021-05?

    The NDC Packaged Code 52119-021-05 is assigned to an UNFINISHED drug package of 5 kg in 1 drum of Melatonin, a bulk ingredient labeled by Swati Spentose Private Limited. The product's dosage form is powder and is administered via form.

    Is NDC 52119-021 included in the NDC Directory?

    Yes, Melatonin is an UNFINISHED PRODUCT with code 52119-021 that is active and included in the NDC Directory. The product was first marketed by Swati Spentose Private Limited on July 01, 2019 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 52119-021-05?

    The 11-digit format is 52119002105. 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
    5-3-252119-021-055-4-252119-0021-05