NDC Package 0781-1359-10 Clemastine Fumarate

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

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:

0781-1359-10

Package Description:

1000 TABLET in 1 BOTTLE

Product Code:

0781-1359

Proprietary 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:

00781135910

Labeler Name:

Sandoz Inc

Sample Package:

FDA Application Number:

ANDA073459

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

10-31-1993

End Marketing Date:

10-31-2016

Listing Expiration Date:

10-31-2016

Exclude Flag:

Code Structure:

0781 - Sandoz Inc
- 0781-1359 - Clemastine Fumarate
  - 0781-1359-10 - 1000 TABLET in 1 BOTTLE

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
0781-1359-01	100 TABLET in 1 BOTTLE
0781-1359-05	500 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0781-1359-10?

The NDC Packaged Code 0781-1359-10 is assigned to a package of 1000 tablet in 1 bottle of Clemastine Fumarate, labeled by Sandoz Inc. The product's dosage form is and is administered via form.

Is NDC 0781-1359 included in the NDC Directory?

The product was first marketed by Sandoz Inc on October 31, 1993 and its listing in the NDC Directory is set to expire on October 31, 2016 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0781-1359-10?

The 11-digit format is 00781135910. 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 4-4-2 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
4-4-2	0781-1359-10	5-4-2	00781-1359-10

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