Ryclora Liquid
NDC Package 15370-150-16

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

Package Information

Ryclora (dexchlorpheniramine maleate) liquids is dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a liquid delivery system. Marketed by Carwin Pharmaceutical Associates, Llc, this product is identified by NDC 15370-150 and is authorized under FDA application ANDA202520.

Identification & Billing

NDC Package Code
15370-150-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
15370-150
11-Digit Billing Format
15370015016
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ryclora
Non-Proprietary Name
Dexchlorpheniramine Maleate
Substance Name
Dexchlorpheniramine Maleate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DEXCHLORPHENIRAMINE MALEATE 2 mg/5mL
Usage Information
Dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms may include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. It also blocks another natural substance made by your body (acetylcholine). Blocking acetylcholine helps lessen symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. 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 medications that 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
Carwin Pharmaceutical Associates, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202520
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-07-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (15370-150). Click a package code to view its specific billing and regulatory data.

15370-150-04
118 mL in 1 BOTTLE, PLASTIC
15370-150-99
20 mL in 1 BOTTLE, PLASTIC

* 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 15370-150-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Ryclora, a human prescription drug labeled by Carwin Pharmaceutical Associates, Llc. This liquid is formulated for oral use and contains dexchlorpheniramine maleate 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 Carwin Pharmaceutical Associates, Llc on October 07, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms may include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. It also blocks another natural substance made by your body (acetylcholine). Blocking acetylcholine helps lessen symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. 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 medications that 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 Carwin Pharmaceutical Associates, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15370015016. 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)
15370-150-16
11-Digit CMS (5-4-2)
15370-0150-16

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