Niacin
NDC 10135-613

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10135-613?
  5. Niacin Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Niacin is a ANDA-approved product labeled by Marlex Pharmaceuticals Inc. Niacin (nicotinic acid) is used to prevent and treat niacin deficiency (pellagra). It is supplied as a orange product. This product entry covers the primary NDC 10135-613 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
10135-613
Proprietary Name:
Niacin
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Product Label ID:
e80aadb4-0533-4887-8dbb-a75f0c739942
FDA Application Number: [6]
ANDA203578
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
02-01-2016
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
ROUND (C48348)
CAPSULE (C48336)
Size(s):
11 MM
19 MM
Imprint(s):
AN;321
AN;323
AN;322
Score:
1

Code Structure Chart

Product Details

What is NDC 10135-613?

The NDC code 10135-613 is assigned by the FDA to the product Niacin. This pharmaceutical product is labeled by Marlex Pharmaceuticals Inc and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 10135-613-05, 10135-613-30, 10135-613-90. 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?

Niacin (nicotinic acid) is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency may result from certain medical conditions (such as alcohol abuse, malabsorption syndrome, Hartnup disease), poor diet, or long-term use of certain medications (such as isoniazid). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacin is also known as vitamin B3, one of the B-complex vitamins. Vitamins help to support the body's ability to make and break down natural compounds (metabolism) needed for good health. Niacinamide (nicotinamide) is a different form of vitamin B3 and does not work the same as niacin. Do not substitute unless directed by your doctor. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Niacin


Niacin is used with diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in your blood and to increase the amount of high density lipoprotein (HDL; ''good cholesterol''). Niacin can be used in a number of situations including the following: alone or in combination with other medications, such as HMG-CoA inhibitors (statins) or bile acid-binding resins; to decrease the risk of another heart attack in patients with high cholesterol who have had a heart attack; to prevent worsening of atherosclerosis (buildup of cholesterol and fats along the walls of the blood vessels) in patients with high cholesterol and coronary artery disease; to reduce the amount of triglycerides (other fatty substances) in the blood in patients with very high triglycerides who are at risk of pancreatic disease (conditions affecting the pancreas, a gland that produces fluid to break down food and hormones to control blood sugar). Niacin is also used to prevent and treat pellagra (niacin deficiency), a disease caused by inadequate diet and other medical problems. Niacin is a B-complex vitamin. At therapeutic doses, niacin is a cholesterol-lowering medication. Results of a clinical study in people with heart disease and well-controlled cholesterol levels that compared people who took niacin and simvastatin with people who took simvastatin alone and found similar results for the two groups in the rate of heart attacks or strokes. Taking niacin along with simvastatin or lovastatin also has not been shown to reduce the risk of heart disease or death compared with the use of niacin, simvastatin, or lovastatin alone. Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with niacin and other medications.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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".