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  5. NDC Package Code: 47335-539-83 Niacin

NDC Package 47335-539-83 Niacin

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
47335-539-83
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
47335-539
Proprietary Name:
Niacin
Non-Proprietary Name:
Niacin
Substance Name:
Niacin
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.
11-Digit NDC Billing Format:
47335053983
NDC to RxNorm Crosswalk:
  • 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sun Pharmaceutical Industries, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • NIACIN 500 mg/1
    • Pharmacologic Class(es):
  • Nicotinic Acid - [EPC] (Established Pharmacologic Class)
  • Nicotinic Acids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA200484
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-27-2014
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    47335-539-08100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    47335-539-181000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    47335-539-8190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    47335-539-88100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 47335-539-83?

    The NDC Packaged Code 47335-539-83 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle of Niacin, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 47335-539 included in the NDC Directory?

    Yes, Niacin with product code 47335-539 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on June 27, 2014 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 47335-539-83?

    The 11-digit format is 47335053983. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-247335-539-835-4-247335-0539-83