NDC 23594-101 Karbinal ER

Carbinoxamine Maleate Suspension, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
23594-101
Proprietary Name:
Karbinal ER
Non-Proprietary Name: [1]
Carbinoxamine Maleate
Substance Name: [2]
Carbinoxamine Maleate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension, Extended Release - A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Aytu Therapeutics, Llc
    Labeler Code:
    23594
    FDA Application Number: [6]
    NDA022556
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    01-03-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    STRAWBERRY (C73417 - STRAWBERRY BANANA)

    Product Packages

    NDC Code 23594-101-01

    Package Description: 2 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

    NDC Code 23594-101-05

    Package Description: 480 mL in 1 BOTTLE, PLASTIC

    Price per Unit: $1.08894 per ML

    Product Details

    What is NDC 23594-101?

    The NDC code 23594-101 is assigned by the FDA to the product Karbinal ER which is a human prescription drug product labeled by Aytu Therapeutics, Llc. The generic name of Karbinal ER is carbinoxamine maleate. The product's dosage form is suspension, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 23594-101-01 2 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic, 23594-101-05 480 ml in 1 bottle, plastic . 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 Karbinal ER?

    Carbinoxamine 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 Karbinal ER 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.

    Which are Karbinal ER UNII Codes?

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

    Which are Karbinal ER 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 Karbinal ER?

    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: 1374770 - carbinoxamine maleate 4 MG in 5 mL 12HR Extended Release Oral Suspension
    • RxCUI: 1374770 - 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension
    • RxCUI: 1374770 - carbinoxamine maleate 4 MG per 5 ML 12 HR Extended Release Oral Suspension
    • RxCUI: 1374776 - Karbinal ER 4 MG in 5 mL 12HR Extended Release Oral Suspension
    • RxCUI: 1374776 - 12 HR carbinoxamine maleate 0.8 MG/ML Extended Release Suspension [Karbinal]

    Which are the Pharmacologic Classes for Karbinal ER?

    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.

    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".