Meclizine Tablet, Chewable
NDC Package 80513-421-02

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

Package Information

Meclizine (meclizine hydrochloride) tablets is doage should be taken 1 hour before travel starts  adults and children 12 years and overtake 1 or 2 tablets once daily or as directed by doctor. This formulation utilizes a tablet, chewable delivery system. Marketed by Advanced Rx Llc, this product is identified by NDC 80513-421 and is authorized under FDA application M009.

Identification & Billing

NDC Package Code
80513-421-02
Package Description
200 TABLET, CHEWABLE in 1 BOTTLE
Product Code
80513-421
11-Digit Billing Format
80513042102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meclizine
Non-Proprietary Name
Meclizine Hydrochloride
Substance Name
Meclizine Hydrochloride
Dosage Form
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MECLIZINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Doage should be taken 1 hour before travel starts  adults and children 12 years and overtake 1 or 2 tablets once daily or as directed by doctor

Regulatory & Marketing

Labeler Name
Advanced Rx Llc
Product Type
Human Otc Drug
FDA Application #
M009
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2024
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 80513-421-02 identifies a specific commercial package of 200 tablet, chewable in 1 bottle of Meclizine, a human over the counter drug labeled by Advanced Rx Llc. This tablet, chewable is formulated for oral use and contains meclizine hydrochloride 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 Advanced Rx Llc on December 01, 2024. The current certification is valid through December 31, 2026.

How is this Advanced Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80513042102. 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)
80513-421-02
11-Digit CMS (5-4-2)
80513-0421-02

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