Genexa Kids Sleepology Tablet, Chewable
NDC Package 69676-0053-1

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

Package Information

Genexa Kids Sleepology (alfalfa, calcarea phosphorica, chamomilla, eschscholtzia californica, melissa officinalis, passiflora incarnata, pulsatilla, scutellaria lateriflora, valeriana officinalis) tablets is uses*addresses sleeplessness and/or restless sleep. This formulation utilizes a tablet, chewable delivery system. Marketed by Genexa Inc., this product is identified by NDC 69676-0053.

Identification & Billing

NDC Package Code
69676-0053-1
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Product Code
69676-0053
11-Digit Billing Format
69676005301

Clinical Specifications

Proprietary Name
Genexa Kids Sleepology
Non-Proprietary Name
Alfalfa, Calcarea Phosphorica, Chamomilla, Eschscholtzia Californica, Melissa Officinalis, Passiflora Incarnata, Pulsatilla, Scutellaria Lateriflora, Valeriana Officinalis
Substance Name
Alfalfa; Eschscholzia Californica; Matricaria Chamomilla Whole; Melissa Officinalis Leaf; Passiflora Incarnata Flowering Top; Pulsatilla Vulgaris; Scutellaria Lateriflora Top; Tribasic Calcium Phosphate; Valerian
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)
Usage Information
Uses*addresses sleeplessness and/or restless sleep.

Regulatory & Marketing

Labeler Name
Genexa Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
01-28-2021
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 69676-0053-1 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 60 tablet, chewable in 1 bottle, plastic of Genexa Kids Sleepology, a human over the counter drug labeled by Genexa Inc.. This tablet, chewable is formulated for oral use and contains alfalfa; eschscholzia californica; matricaria chamomilla whole; melissa officinalis leaf; passiflora incarnata flowering top; pulsatilla vulgaris; scutellaria lateriflora top; tribasic calcium phosphate; valerian 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 Genexa Inc. on January 28, 2021. The current certification is valid through December 31, 2026.

How is this Genexa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69676005301. 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)
69676-0053-1
11-Digit CMS (5-4-2)
69676-0053-01

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