NDC Package 73377-061-01 Clemastine Fumarate

Powder - View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:

73377-061-01

Package Description:

25 g in 1 JAR

Product Code:

73377-061

Non-Proprietary Name:

Clemastine Fumarate

Substance Name:

Clemastine Fumarate

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).

11-Digit NDC Billing Format:

73377006101

Product Type:

Bulk Ingredient

Labeler Name:

Ax Pharmaceutical Corp

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Active Ingredient(s):

CLEMASTINE FUMARATE 1 g/g

Sample Package:

N/A

Marketing Category:

BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.

Start Marketing Date:

07-15-2020

End Marketing Date:

09-17-2027

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

73377 - Ax Pharmaceutical Corp
- 73377-061 -
  - 73377-061-01 - 25 g in 1 JAR

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
73377-061-02	5 g in 1 JAR

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 73377-061-01?

The NDC Packaged Code 73377-061-01 is assigned to an UNFINISHED drug package of 25 g in 1 jar of Clemastine Fumarate, a bulk ingredient labeled by Ax Pharmaceutical Corp. The product's dosage form is powder and is administered via form.

Is NDC 73377-061 included in the NDC Directory?

Yes, Clemastine Fumarate is an UNFINISHED PRODUCT with code 73377-061 that is active and included in the NDC Directory. The product was first marketed by Ax Pharmaceutical Corp on July 15, 2020.

What is the 11-digit format for NDC 73377-061-01?

The 11-digit format is 73377006101. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	73377-061-01	5-4-2	73377-0061-01

Table of Contents