Dextromethorphan Hbr 15 Mg Capsule, Liquid Filled
NDC Package 53345-028-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dextromethorphan Hbr 15 Mg (dextromethorphan hbr) capsules is a medication used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This formulation utilizes a capsule, liquid filled delivery system. Marketed by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd., this product is identified by NDC 53345-028 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53345-028-01
Package Description
1 BAG in 1 BOX / 12000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
53345-028
11-Digit Billing Format
53345002801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dextromethorphan Hbr 15 Mg
Non-Proprietary Name
Dextromethorphan Hbr
Substance Name
Dextromethorphan Hydrobromide
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-10-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53345-028-01 identifies a specific commercial 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 Pharmaceuticals (wuhan) Co., Ltd.. This capsule, liquid filled is formulated for oral use and contains dextromethorphan hydrobromide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd. on December 10, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

How is this Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53345002801. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
53345-028-01
11-Digit CMS (5-4-2)
53345-0028-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.