Melatonin Powder
NDC 54236-040
View dosage, usage, ingredients, routes, and UNII mappings.
Product 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 is a BULK INGREDIENT-approved product labeled by Flamma S.p.a.. Melatonin has been used for short-term treatment of trouble sleeping (insomnia) due to sleep cycle disorders and time changes ("jet lag"). It is supplied as a powder. This product entry covers the primary NDC 54236-040 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
54236-040
Proprietary Name:
Melatonin
Non-Proprietary Name: [1]
Melatonin
Substance Name: [2]
Melatonin
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Powder
- An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
54236
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Marketing Timeline
Start Marketing Date: [9]
05-17-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Structure Chart
Product Details
What is NDC 54236-040?
The NDC code 54236-040 is assigned by the FDA to the product Melatonin. It is commonly known by its generic name, melatonin. This pharmaceutical product is labeled by Flamma S.p.a. and is currently categorized as listed product. The medication is a powder. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54236-040-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- MELATONIN 1 kg/kg - A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
What is an Unfinished Product? This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.
