Karbinal Suspension, Extended Release
NDC Package 23594-101-05

11-digit billing NDC: 23594010105 · Billing unit: ML · 480 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Karbinal (carbinoxamine maleate) suspension is karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of:Seasonal and perennial allergic rhinitisVasomotor rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild, uncomplicated allergic skin manifestations of urticaria and angioedemaDermatographismAs therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled Amelioration of the severity of allergic reactions to blood or plasma. 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
23594-101-05
Package Description
480 mL in 1 BOTTLE, PLASTIC
Product Code
23594-101
11-Digit Billing Format
23594010105
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
480 ML
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
Karbinal ER is indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of:Seasonal and perennial allergic rhinitisVasomotor rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild, uncomplicated allergic skin manifestations of urticaria and angioedemaDermatographismAs therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled Amelioration of the severity of allergic reactions to blood or plasma

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

23594-101-01
2 BOTTLE, PLASTIC in 1 CARTON / 30 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 23594-101-05 identifies a specific commercial package of 480 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23594010105. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 480 total billable units per package. 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)
23594-101-05
11-Digit CMS (5-4-2)
23594-0101-05

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