Carbinoxamine Maleate Tablet
NDC Package 64950-211-01

11-digit billing NDC: 64950021101 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Carbinoxamine Maleate tablets is carbinoxamine maleate is effective for the symptomatic treatment of:Seasonal and perennial allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Dermatographism.As 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 tablet delivery system. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-211 and is authorized under FDA application ANDA040442.

Identification & Billing

NDC Package Code
64950-211-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
64950-211
11-Digit Billing Format
64950021101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Carbinoxamine Maleate
Non-Proprietary Name
Carbinoxamine Maleate
Substance Name
Carbinoxamine Maleate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CARBINOXAMINE MALEATE 4 mg/1
Pharmacologic Class
Usage Information
Carbinoxamine maleate is effective for the symptomatic treatment of:Seasonal and perennial allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Dermatographism.As 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
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-02-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64950-211-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Carbinoxamine Maleate, a human prescription drug labeled by Genus Lifesciences Inc.. This tablet 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 Genus Lifesciences Inc. on August 02, 2023. The current certification is valid through December 31, 2027.

How is this Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950021101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
64950-211-01
11-Digit CMS (5-4-2)
64950-0211-01

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