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  5. NDC Package Code: 53345-011-01 Dextromethorphan Hbr 15 Mg

NDC Package 53345-011-01 Dextromethorphan Hbr 15 Mg

Dextromethorphan Hbr Capsule, Liquid Filled 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:
53345-011-01
Package Description:
1 BAG in 1 BOX / 12000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code:
53345-011
Proprietary Name:
Dextromethorphan Hbr 15 Mg
Non-Proprietary Name:
Dextromethorphan Hbr
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:
53345001101
NDC to RxNorm Crosswalk:
  • RxCUI: 1090487 - dextromethorphan HBr 15 MG Oral Capsule
  • RxCUI: 1090487 - dextromethorphan hydrobromide 15 MG Oral Capsule
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Humanwell Puracap Pharmaceutical (wuhan), Ltd.
    Dosage Form:
    Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
    • Pharmacologic Class(es):
  • 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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    01-30-2014
    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.

    Frequently Asked Questions

    What is NDC 53345-011-01?

    The NDC Packaged Code 53345-011-01 is assigned to a package of 1 bag in 1 box / 12000 capsule, liquid filled in 1 bag of Dextromethorphan Hbr 15 Mg, a human over the counter drug labeled by Humanwell Puracap Pharmaceutical (wuhan), Ltd.. The product's dosage form is capsule, liquid filled and is administered via oral form.

    Is NDC 53345-011 included in the NDC Directory?

    Yes, Dextromethorphan Hbr 15 Mg with product code 53345-011 is active and included in the NDC Directory. The product was first marketed by Humanwell Puracap Pharmaceutical (wuhan), Ltd. on January 30, 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 53345-011-01?

    The 11-digit format is 53345001101. 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
    5-3-253345-011-015-4-253345-0011-01