Dexchlorpheniramine Maleate
NDC Package 60432-539-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Dexchlorpheniramine Maleate is dexchlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. Marketed by Morton Grove Pharmaceuticals, Inc., this product is identified by NDC 60432-539 and is authorized under FDA application ANDA088251.

Identification & Billing

NDC Package Code
60432-539-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
11-Digit Billing Format
60432053916
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

Clinical Specifications

Proprietary Name
Dexchlorpheniramine Maleate
Dosage Form
-
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
Morton Grove Pharmaceuticals, Inc.
FDA Application #
ANDA088251
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-23-1984
End Marketing Date
11-08-2012
Listing Expiration
11-08-2012
Exclude Flag
D
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 60432-539-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Dexchlorpheniramine Maleate, labeled by Morton Grove Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Morton Grove Pharmaceuticals, Inc. on March 23, 1984. The current certification is valid through November 08, 2012.

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 Morton Grove Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60432053916. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
60432-539-16
11-Digit CMS (5-4-2)
60432-0539-16

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