Melatonin Powder
NDC Package 54236-040-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Melatonin powders is melatonin has been used for short-term treatment of trouble sleeping (insomnia) due to sleep cycle disorders and time changes ("jet lag"). This formulation utilizes a powder delivery system. Marketed by Flamma S.p.a., this product is identified by NDC 54236-040.

Identification & Billing

NDC Package Code
54236-040-01
Package Description
20 kg in 1 DRUM
Product Code
54236-040
11-Digit Billing Format
54236004001

Clinical Specifications

Proprietary Name
Melatonin
Non-Proprietary Name
Melatonin
Substance Name
Melatonin
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
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.

Regulatory & Marketing

Labeler Name
Flamma S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-17-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54236-040-01 identifies a specific commercial package of 20 kg in 1 drum of Melatonin (UNFINISHED drug), a bulk ingredient labeled by Flamma S.p.a.. This powder is formulated for use and contains melatonin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Flamma S.p.a. on May 17, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Flamma S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54236004001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
54236-040-01
11-Digit CMS (5-4-2)
54236-0040-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.