Loratadine Tablet, Orally Disintegrating
NDC Package 43598-758-30

11-digit billing NDC: 43598075830
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Loratadine tablets is place 1 tablet on tongue; tablet disintegrates, with or without wateradults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 43598-758 and is authorized under FDA application ANDA213294.

Identification & Billing

NDC Package Code
43598-758-30
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
43598-758
11-Digit Billing Format
43598075830
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Loratadine
Non-Proprietary Name
Loratadine
Substance Name
Loratadine
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LORATADINE 10 mg/1
Usage Information
Place 1 tablet on tongue; tablet disintegrates, with or without wateradults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hourschildren under 6 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA213294
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-19-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43598-758). Click a package code to view its specific billing and regulatory data.

43598-758-10
1 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

* 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 43598-758-30 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack of Loratadine, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. This tablet, orally disintegrating 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 Dr. Reddy's Laboratories Inc. on May 19, 2021. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598075830. 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)
43598-758-30
11-Digit CMS (5-4-2)
43598-0758-30

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