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  4. NDC Product Code: 10702-017 Chlorphen-12

NDC 10702-017 Chlorphen-12

Chlorpheniramine Maleate Tablet, Film Coated, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10702-017?
  5. Chlorphen-12 Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
10702-017
Proprietary Name:
Chlorphen-12
Non-Proprietary Name: [1]
Chlorpheniramine Maleate
Substance Name: [2]
Chlorpheniramine Maleate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Kvk-tech, Inc.
    Labeler Code:
    10702
    Product Label ID:
    84409269-fe9b-469e-9a66-27b1475231a3
    FDA Application Number: [6]
    ANDA040829
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-15-2010
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    ORANGE (C48331)
    Shape:
    ROUND (C48348)
    Size(s):
    7 MM
    Imprint(s):
    CHLORPHEN;12
    Score:
    1

    Product Packages

    NDC Code 10702-017-01

    Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 10702-017-06

    Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.23057 per EA

    NDC Code 10702-017-24

    Package Description: 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON

    Price per Unit: $0.23057 per EA

    NDC Code 10702-017-54

    Package Description: 50 PACKAGE in 1 CARTON / 4 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (10702-017-04)

    Product Details

    What is NDC 10702-017?

    The NDC code 10702-017 is assigned by the FDA to the product Chlorphen-12 which is a human over the counter drug product labeled by Kvk-tech, Inc.. The generic name of Chlorphen-12 is chlorpheniramine maleate. The product's dosage form is tablet, film coated, extended release and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 10702-017-01 100 tablet, film coated, extended release in 1 bottle , 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). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Chlorphen-12?

    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).

    What are Chlorphen-12 Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • CHLORPHENIRAMINE MALEATE 12 mg/1 - A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.

    Which are Chlorphen-12 UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Chlorphen-12 Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Chlorphen-12?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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

    Which are the Pharmacologic Classes for Chlorphen-12?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Desmopressin


    Desmopressin is used to control the symptoms of a certain type of diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine). Desmopressin is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery. Desmopressin is also used to control bed-wetting. Desmopressin is in a class of medications called hormones. It works by replacing vasopressin, a hormone that is normally produced in the body to help balance the amount of water and salt.
    [Learn More]


    Chlorpheniramine


    Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".