Niacin
NDC Package 10135-613-90
Package Information
Niacin is (nicotinic acid) is used to prevent and treat niacin deficiency (pellagra). Marketed by Marlex Pharmaceuticals Inc, this product is identified by NDC 10135-613 and is authorized under FDA application ANDA203578.
Identification & Billing
- RxCUI: 1098134 - niacin 1000 MG 24HR Extended Release Oral Tablet
- RxCUI: 1098134 - 24 HR niacin 1000 MG Extended Release Oral Tablet
- RxCUI: 1098134 - 24 HR nicotinic acid 1000 MG Extended Release Oral Tablet
- RxCUI: 1098134 - 24 HR vitamin B3 1000 MG Extended Release Oral Tablet
- RxCUI: 1098134 - 24 HR vit-B3 1000 MG Extended Release Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 10135 - Marlex Pharmaceuticals Inc
- 10135-613 - Niacin
- 10135-613-90 - 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
- 10135-613 - Niacin
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 (10135-613). Click a package code to view its specific billing and regulatory data.
* 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 10135-613-90 identifies a specific commercial package of 90 tablet, extended release in 1 bottle, plastic of Niacin, labeled by Marlex Pharmaceuticals Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Marlex Pharmaceuticals Inc on February 01, 2016. The current certification is valid through December 31, 2019.
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 Marlex Pharmaceuticals Inc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 10135061390. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.