Chlorphen-12 Tablet, Film Coated, Extended Release
NDC Package 10702-017-01

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

Chlorphen-12 (chlorpheniramine maleate) tablets is chlorpheniramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Kvk-tech, Inc., this product is identified by NDC 10702-017 and is authorized under FDA application ANDA040829.

Identification & Billing

NDC Package Code
10702-017-01
Package Description
100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
10702-017
11-Digit Billing Format
10702001701
RxNorm Crosswalk
  • RxCUI: 1363288 - chlorpheniramine maleate 12 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1363288 - 12 HR chlorpheniramine maleate 12 MG Extended Release Oral Tablet
  • RxCUI: 1363288 - chlorpheniramine maleate 12 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Chlorphen-12
Non-Proprietary Name
Chlorpheniramine Maleate
Substance Name
Chlorpheniramine Maleate
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CHLORPHENIRAMINE MALEATE 12 mg/1
Pharmacologic Class
Usage Information
Chlorpheniramine 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
Kvk-tech, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA040829
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2010
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 (10702-017). Click a package code to view its specific billing and regulatory data.

10702-017-06
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
10702-017-24
24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON
10702-017-54
50 PACKAGE in 1 CARTON / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04)

* 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 10702-017-01 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Chlorphen-12, a human over the counter drug labeled by Kvk-tech, Inc.. This tablet, film coated, extended release is formulated for oral use and contains chlorpheniramine 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 Kvk-tech, Inc. on June 15, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Chlorpheniramine 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 Kvk-tech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10702001701. 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)
10702-017-01
11-Digit CMS (5-4-2)
10702-0017-01

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