Ez Nite Sleep
NDC Package 63868-014-24

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.

Ez Nite Sleep is take only one dose per day (24 hours) - see Overdose warning swallow whole; do not crush, chew, or dissolve adults & children 12 yrs & over one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor. Marketed by Quality Choice (chain Drug Marketing Association), this product is identified by NDC 63868-014 and is authorized under FDA application part338.

Identification & Billing

NDC Package Code
63868-014-24
Package Description
2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
63868-014
11-Digit Billing Format
63868001424
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ez Nite Sleep Nighttime Sleep-aid
Dosage Form
-
Usage Information
Take only one dose per day (24 hours) - see Overdose warning swallow whole; do not crush, chew, or dissolve adults & children 12 yrs & over one dose = TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Regulatory & Marketing

Labeler Name
Quality Choice (chain Drug Marketing Association)
FDA Application #
part338
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-11-2013
Listing Expiration
12-31-2019
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 (63868-014). Click a package code to view its specific billing and regulatory data.

63868-014-48
4 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

* 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 63868-014-24 identifies a specific commercial package of 2 blister pack in 1 carton / 12 capsule, liquid filled in 1 blister pack of Ez Nite Sleep Nighttime Sleep-aid, labeled by Quality Choice (chain Drug Marketing Association). 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 Quality Choice (chain Drug Marketing Association) on March 11, 2013. The current certification is valid through December 31, 2019.

How is this Quality Choice (chain Drug Marketing Association) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868001424. 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)
63868-014-24
11-Digit CMS (5-4-2)
63868-0014-24

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