Handy Solutions 24 Hour Allergy Tablet, Film Coated
NDC Package 67751-163-01

11-digit billing NDC: 67751016301
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Handy Solutions 24 Hour Allergy (loratadine) tablets is adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours Children under 12 years: do not give to children under 12 years of age Consumer with liver or kidney disease: ask a doctor before using. This formulation utilizes a tablet, film coated delivery system. Marketed by Navajo Manufacturing Company Inc., this product is identified by NDC 67751-163 and is authorized under FDA application ANDA076134.

Identification & Billing

NDC Package Code
67751-163-01
Package Description
1 POUCH in 1 CARTON / 6 TABLET, FILM COATED in 1 POUCH
Product Code
67751-163
11-Digit Billing Format
67751016301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Handy Solutions 24 Hour Allergy
Non-Proprietary Name
Loratadine
Substance Name
Loratadine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LORATADINE 10 mg/1
Usage Information
Adults and children (12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours Children under 12 years: do not give to children under 12 years of age Consumer with liver or kidney disease: ask a doctor before using

Regulatory & Marketing

Labeler Name
Navajo Manufacturing Company Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA076134
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-22-2016
Listing Expiration
12-31-2026
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 (67751-163). Click a package code to view its specific billing and regulatory data.

67751-163-02
1 POUCH in 1 CARTON / 2 TABLET, FILM COATED in 1 POUCH

* 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 67751-163-01 identifies a specific commercial package of 1 pouch in 1 carton / 6 tablet, film coated in 1 pouch of Handy Solutions 24 Hour Allergy, a human over the counter drug labeled by Navajo Manufacturing Company Inc.. This tablet, film coated is formulated for oral use and contains loratadine 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 Navajo Manufacturing Company Inc. on September 22, 2016. The current certification is valid through December 31, 2026.

How is this Navajo Manufacturing Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67751016301. 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)
67751-163-01
11-Digit CMS (5-4-2)
67751-0163-01

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