Meclizine Hcl 25 Mg Tablet
NDC Package 69618-028-01

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

Meclizine Hcl 25 Mg (meclizine hcl) tablets is meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. This formulation utilizes a tablet delivery system. Marketed by Reliable 1 Laboratories Llc, this product is identified by NDC 69618-028 and is authorized under FDA application M009.

Identification & Billing

NDC Package Code
69618-028-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
69618-028
11-Digit Billing Format
69618002801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meclizine Hcl 25 Mg
Non-Proprietary Name
Meclizine Hcl
Substance Name
Meclizine Hydrochloride
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)
MECLIZINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to reduce dizziness and loss of balance (vertigo) caused by inner ear problems.

Regulatory & Marketing

Labeler Name
Reliable 1 Laboratories Llc
Product Type
Human Otc Drug
FDA Application #
M009
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-01-2015
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 (69618-028). Click a package code to view its specific billing and regulatory data.

69618-028-10
1000 TABLET in 1 BOTTLE, PLASTIC

* 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 69618-028-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Meclizine Hcl 25 Mg, a human over the counter drug labeled by Reliable 1 Laboratories Llc. This tablet 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 Reliable 1 Laboratories Llc on November 01, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Meclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to reduce dizziness and loss of balance (vertigo) caused by inner ear problems.

How is this Reliable 1 Laboratories Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69618002801. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
69618-028-01
11-Digit CMS (5-4-2)
69618-0028-01

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