Niacin Tablet
NDC 33342-187

Niacin 500 mg/1 · Tablet (oral)
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 33342-187?
  5. Niacin Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Niacin is a ANDA-approved product labeled by Macleods Pharmaceuticals Limited. This medication is typically used as a nicotinic acid [epc]. It is supplied as a orange tablet for oral administration. This product entry covers the primary NDC 33342-187 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
33342-187
Proprietary Name:
Niacin
Non-Proprietary Name: [1]
Niacin
Substance Name: [2]
Niacin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Macleods Pharmaceuticals Limited
Labeler Code:
33342
Product Label ID:
52ad4a6a-81cc-4b03-b8b1-3bd9a1d4064e
FDA Application Number: [6]
ANDA204934
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-03-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
ORANGE (C48331)
Shape:
OVAL (C48345)
Size(s):
16 MM
Imprint(s):
L55
Score:
1

Code Structure Chart

Product Details

What is NDC 33342-187?

The NDC code 33342-187 is assigned by the FDA to the product Niacin. This pharmaceutical product is labeled by Macleods Pharmaceuticals Limited and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 33342-187-10, 33342-187-11. 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?

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. 1. Niacin extended-release tablet is indicated to reduce   elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. 2. In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. 3. In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. 4. Niacin extended-release tablet in combination with a bile acid binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia. 5. Niacin is also indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Limitations of Use Addition of niacin extended-release tablets did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH) [see Warnings and Precautions ( 5.1)].

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.
  • NIACIN 500 mg/1 - A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of 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 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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".