Niacin Tablet, Film Coated, Extended Release
NDC Package 47335-613-83

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Niacin tablets is niacin (nicotinic acid) is used to prevent and treat niacin deficiency (pellagra). This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 47335-613 and is authorized under FDA application ANDA200484.

Identification & Billing

NDC Package Code
47335-613-83
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
47335-613
11-Digit Billing Format
47335061383
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Niacin
Non-Proprietary Name
Niacin
Substance Name
Niacin
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NIACIN 1000 mg/1
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200484
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (47335-613). Click a package code to view its specific billing and regulatory data.

47335-613-08
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
47335-613-18
1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
47335-613-81
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
47335-613-88
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

* 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 47335-613-83 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Niacin, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This tablet, film coated, extended release is formulated for oral use and contains niacin 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 Sun Pharmaceutical Industries, Inc. on June 27, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47335061383. 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)
47335-613-83
11-Digit CMS (5-4-2)
47335-0613-83

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