Sunmark Loratadine Odt
NDC Package 49348-930-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sunmark Loratadine Odt 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. Marketed by Sunmark, this product is identified by NDC 49348-930 and is authorized under FDA application ANDA077153.

Identification & Billing

NDC Package Code
49348-930-01
Package Description
10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
49348-930
11-Digit Billing Format
49348093001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sunmark Loratadine Odt
Dosage Form
-
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
Sunmark
FDA Application #
ANDA077153
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2007
Listing Expiration
12-31-2019
Exclude Flag
I
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 (49348-930). Click a package code to view its specific billing and regulatory data.

49348-930-44
30 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 49348-930-01 identifies a specific commercial package of 10 tablet, orally disintegrating in 1 blister pack of Sunmark Loratadine Odt, labeled by Sunmark. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sunmark on August 31, 2007. The current certification is valid through December 31, 2019.

How is this Sunmark product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348093001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
49348-930-01
11-Digit CMS (5-4-2)
49348-0930-01

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