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  5. NDC Package Code: 0536-1446-34 Rugby Mucus Relief Dm Er

NDC Package 0536-1446-34 Rugby Mucus Relief Dm Er

Dextromethorphan Hydrobromide,Guaifenesin 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:
0536-1446-34
Package Description:
1 BOTTLE in 1 CARTON / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
0536-1446
Proprietary Name:
Rugby Mucus Relief Dm Er
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Guaifenesin
Substance Name:
Dextromethorphan Hydrobromide; Guaifenesin
Usage Information:
•do not crush, chew, or break tablet•take with a full glass of water•this product can be administered without regard for timing of meals•adults and children 12 years and older:1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours •children under 12 years of age: do not use
11-Digit NDC Billing Format:
00536144634
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:
Rugby Laboratories
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):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA207602
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-02-2025
Listing Expiration Date:
12-31-2026
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 0536-1446-34?

The NDC Packaged Code 0536-1446-34 is assigned to a package of 1 bottle in 1 carton / 20 tablet, extended release in 1 bottle of Rugby Mucus Relief Dm Er, a human over the counter drug labeled by Rugby Laboratories. The product's dosage form is tablet, extended release and is administered via oral form.

Is NDC 0536-1446 included in the NDC Directory?

Yes, Rugby Mucus Relief Dm Er with product code 0536-1446 is active and included in the NDC Directory. The product was first marketed by Rugby Laboratories on April 02, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0536-1446-34?

The 11-digit format is 00536144634. 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
4-4-20536-1446-345-4-200536-1446-34