1. Home
  2. Labeler Index
  3. Aytu Therapeutics, Llc
  4. 23594-101
  5. NDC Package Code: 23594-101-01 Karbinal ER

NDC Package 23594-101-01 Karbinal ER

Carbinoxamine Maleate Suspension, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
23594-101-01
Package Description:
2 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC
Product Code:
23594-101
Proprietary Name:
Karbinal ER
Non-Proprietary Name:
Carbinoxamine Maleate
Substance Name:
Carbinoxamine Maleate
Usage Information:
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).
11-Digit NDC Billing Format:
23594010101
NDC to RxNorm Crosswalk:
  • 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Aytu Therapeutics, Llc
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CARBINOXAMINE MALEATE 4 mg/5mL
    • Pharmacologic Class(es):
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA022556
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-03-2014
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    23594-101-05480 mL in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 23594-101-01?

    The NDC Packaged Code 23594-101-01 is assigned to a package of 2 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic of Karbinal ER, a human prescription drug labeled by Aytu Therapeutics, Llc. The product's dosage form is suspension, extended release and is administered via oral form.

    Is NDC 23594-101 included in the NDC Directory?

    Yes, Karbinal ER with product code 23594-101 is active and included in the NDC Directory. The product was first marketed by Aytu Therapeutics, Llc on January 03, 2014 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 23594-101-01?

    The 11-digit format is 23594010101. 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 5-3-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-223594-101-015-4-223594-0101-01