Loratadine Tablet
NDC Package 69848-019-10

11-digit billing NDC: 69848001910
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Loratadine tablets is ■adults and children6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours.■children under 6 years of age: ask a doctor ■consumers with liver or kidney disease: ask a doctor. This formulation utilizes a tablet delivery system. Marketed by Granules Usa, Inc., this product is identified by NDC 69848-019 and is authorized under FDA application ANDA210722.

Identification & Billing

NDC Package Code
69848-019-10
Package Description
100 TABLET in 1 BOTTLE
Product Code
69848-019
11-Digit Billing Format
69848001910
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loratadine
Non-Proprietary Name
Loratadine
Substance Name
Loratadine
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)
LORATADINE 10 mg/1
Usage Information
■adults and children6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours.■children under 6 years of age: ask a doctor ■consumers with liver or kidney disease: ask a doctor

Regulatory & Marketing

Labeler Name
Granules Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA210722
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-26-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69848-019-10 identifies a specific commercial package of 100 tablet in 1 bottle of Loratadine, a human over the counter drug labeled by Granules Usa, Inc.. This tablet 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 Granules Usa, Inc. on July 26, 2021. The current certification is valid through December 31, 2026.

How is this Granules Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69848001910. 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)
69848-019-10
11-Digit CMS (5-4-2)
69848-0019-10

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