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  5. NDC Package Code: 51316-065-67 Cough And Congestion Extended Release

NDC Package 51316-065-67 Cough And Congestion Extended Release

Guaifenesin And Dextromethorphan Hbr Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
51316-065-67
Package Description:
2 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
51316-065
Proprietary Name:
Cough And Congestion Extended Release
Non-Proprietary Name:
Guaifenesin And Dextromethorphan Hbr
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin
Usage Information:
Do not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for timing of mealsadults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hourschildren under 12 years of age: do not use
11-Digit NDC Billing Format:
51316006567
NDC to RxNorm Crosswalk:
  • RxCUI: 1298324 - guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1298324 - 12 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral Tablet
  • RxCUI: 1298324 - dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral Tablet
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cvs Pharmacy, Inc.
    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 30 mg/1
  • GUAIFENESIN 600 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:
    ANDA206941
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2024
    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.

    Frequently Asked Questions

    What is NDC 51316-065-67?

    The NDC Packaged Code 51316-065-67 is assigned to a package of 2 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack of Cough And Congestion Extended Release, a human over the counter drug labeled by Cvs Pharmacy, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 51316-065 included in the NDC Directory?

    Yes, Cough And Congestion Extended Release with product code 51316-065 is active and included in the NDC Directory. The product was first marketed by Cvs Pharmacy, Inc. on April 01, 2024 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 51316-065-67?

    The 11-digit format is 51316006567. 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
    5-3-251316-065-675-4-251316-0065-67