1. Home
  2. Labeler Index
  3. Haleon Us Holdings Llc
  4. 0031-8765
  5. NDC Package Code: 0031-8765-08 Robitussin Maximum Strength 12 Hour Cough And Mucus Relief

NDC Package 0031-8765-08 Robitussin Maximum Strength 12 Hour Cough And Mucus Relief

Dextromethorphan Hydrobromide,Guaifenesin Tablet, 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:
0031-8765-08
Package Description:
1 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
0031-8765
Proprietary Name:
Robitussin Maximum Strength 12 Hour Cough And Mucus Relief
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Guaifenesin
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin
Usage Information:
Useshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productivetemporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep
11-Digit NDC Billing Format:
00031876508
NDC to RxNorm Crosswalk:
  • RxCUI: 1099074 - guaiFENesin 1200 MG / dextromethorphan HBr 60 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1099074 - 12 HR dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG Extended Release Oral Tablet
  • RxCUI: 1099074 - dextromethorphan hydrobromide 60 MG / guaifenesin 1200 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings Llc
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 60 mg/1
  • GUAIFENESIN 1200 mg/1
    • Pharmacologic Class(es):
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA207602
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-14-2019
    Listing Expiration Date:
    12-31-2025
    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
    0031-8765-041 BLISTER PACK in 1 CARTON / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
    0031-8765-162 BLISTER PACK in 1 CARTON / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0031-8765-08?

    The NDC Packaged Code 0031-8765-08 is assigned to a package of 1 blister pack in 1 carton / 8 tablet, extended release in 1 blister pack of Robitussin Maximum Strength 12 Hour Cough And Mucus Relief, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 0031-8765 included in the NDC Directory?

    Yes, Robitussin Maximum Strength 12 Hour Cough And Mucus Relief with product code 0031-8765 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on June 14, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0031-8765-08?

    The 11-digit format is 00031876508. 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
    4-4-20031-8765-085-4-200031-8765-08