Meclizine Hydrochloride
NDC Package 50436-3988-3

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.

Meclizine Hydrochloride is iNDICATIONSBased on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows:Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system.Final classification of the less than effective indications required further investigation. Marketed by Unit Dose Services, this product is identified by NDC 50436-3988 and is authorized under FDA application ANDA087128.

Identification & Billing

NDC Package Code
50436-3988-3
Package Description
90 TABLET in 1 BOTTLE
Product Code
50436-3988
11-Digit Billing Format
50436398803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meclizine Hydrochloride
Dosage Form
-
Usage Information
INDICATIONSBased on a review of this drug by the National Academy of Sciences – National Research Council and/or other information, FDA has classified the indications as follows:Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.Possibly Effective: Management of vertigo associated with diseases affecting the vestibular system.Final classification of the less than effective indications required further investigation.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA087128
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-1981
Listing Expiration
12-31-2020
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 (50436-3988). Click a package code to view its specific billing and regulatory data.

50436-3988-1
30 TABLET in 1 BOTTLE

* 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 50436-3988-3 identifies a specific commercial package of 90 tablet in 1 bottle of Meclizine Hydrochloride, labeled by Unit Dose Services. 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 Unit Dose Services on June 03, 1981. The current certification is valid through December 31, 2020.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436398803. 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)
50436-3988-3
11-Digit CMS (5-4-2)
50436-3988-03

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