Clemastine Fumarate Syrup
NDC Package 64950-324-12

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

Package Information

Clemastine Fumarate syrups is clemastine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a syrup delivery system. Marketed by Genus Lifesciences, this product is identified by NDC 64950-324 and is authorized under FDA application ANDA073399.

Identification & Billing

NDC Package Code
64950-324-12
Package Description
120 mL in 1 BOTTLE
Product Code
64950-324
11-Digit Billing Format
64950032412
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clemastine Fumarate
Non-Proprietary Name
Clemastine Fumarate
Substance Name
Clemastine Fumarate
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLEMASTINE FUMARATE .67 mg/5mL
Usage Information
Clemastine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms 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. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve 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. Therefore, 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 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
Genus Lifesciences
Product Type
Human Prescription Drug
FDA Application #
ANDA073399
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-22-2024
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 64950-324-12 identifies a specific commercial package of 120 ml in 1 bottle of Clemastine Fumarate, a human prescription drug labeled by Genus Lifesciences. This syrup is formulated for oral use and contains clemastine fumarate 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 Genus Lifesciences on November 22, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Clemastine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms 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. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve 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. Therefore, 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 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 Genus Lifesciences product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950032412. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 total billable units per package. 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)
64950-324-12
11-Digit CMS (5-4-2)
64950-0324-12

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