Claritin Tablet
NDC Package 85237-1630-4

11-digit billing NDC: 85237163004
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Claritin (loratadine) tablets is directionsadults 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 delivery system. Marketed by Select Consumer Group, this product is identified by NDC 85237-1630 and is authorized under FDA application ANDA075209.

Identification & Billing

NDC Package Code
85237-1630-4
Package Description
25 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET in 1 POUCH
Product Code
85237-1630
11-Digit Billing Format
85237163004
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Claritin
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
Directionsadults 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
Select Consumer Group
Product Type
Human Otc Drug
FDA Application #
ANDA075209
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2020
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 (85237-1630). Click a package code to view its specific billing and regulatory data.

85237-1630-1
1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK
85237-1630-3
20 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET 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 85237-1630-4 identifies a specific commercial package of 25 pouch in 1 box, unit-dose / 1 tablet in 1 pouch of Claritin, a human over the counter drug labeled by Select Consumer Group. 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 Select Consumer Group on December 01, 2020. The current certification is valid through December 31, 2026.

How is this Select Consumer Group product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85237163004. 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 (5-4-1)
85237-1630-4
11-Digit CMS (5-4-2)
85237-1630-04

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