NDC Package 0031-8753-03 Robitussin 12 Hour Cough Relief

Dextromethorphan Polistirex Suspension, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

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:
0031-8753-03
Package Description:
1 BOTTLE in 1 CARTON / 89 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Robitussin 12 Hour Cough Relief
Non-Proprietary Name:
Dextromethorphan Polistirex
Substance Name:
Dextromethorphan Hydrobromide
Usage Information:
This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains dextromethorphan. It is a cough suppressant that works by decreasing the feeling of needing to cough. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
11-Digit NDC Billing Format:
00031875303
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    Dosage Form:
    Suspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Sample Package:
    No
    FDA Application Number:
    ANDA091135
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-01-2015
    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.

    Frequently Asked Questions

    What is NDC 0031-8753-03?

    The NDC Packaged Code 0031-8753-03 is assigned to a package of 1 bottle in 1 carton / 89 ml in 1 bottle of Robitussin 12 Hour Cough Relief, a human over the counter drug labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is suspension, extended release and is administered via oral form.

    Is NDC 0031-8753 included in the NDC Directory?

    Yes, Robitussin 12 Hour Cough Relief with product code 0031-8753 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc on July 01, 2015 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 NDC billing unit for package 0031-8753-03?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0031-8753-03?

    The 11-digit format is 00031875303. 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 4-4-2 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
    4-4-20031-8753-035-4-200031-8753-03