Karbinal Suspension, Extended Release
NDC Package 23594-101-01

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

Karbinal (carbinoxamine maleate) suspension is carbinoxamine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. This formulation utilizes a suspension, extended release delivery system. Marketed by Aytu Therapeutics, Llc, this product is identified by NDC 23594-101 and is authorized under FDA application NDA022556.

Identification & Billing

NDC Package Code
23594-101-01
Package Description
2 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC
Product Code
23594-101
11-Digit Billing Format
23594010101
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]

Clinical Specifications

Proprietary Name
Karbinal ER
Non-Proprietary Name
Carbinoxamine Maleate
Substance Name
Carbinoxamine Maleate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBINOXAMINE MALEATE 4 mg/5mL
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Aytu Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022556
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-03-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (23594-101). Click a package code to view its specific billing and regulatory data.

23594-101-05
480 mL in 1 BOTTLE, PLASTIC

* 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 23594-101-01 identifies a specific commercial 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. This suspension, extended release is formulated for oral use and contains carbinoxamine 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 Aytu Therapeutics, Llc on January 03, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Aytu Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23594010101. 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)
23594-101-01
11-Digit CMS (5-4-2)
23594-0101-01

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