Nighttime Sleep Aid
NDC Package 55315-003-12

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Nighttime Sleep Aid is take only one dose per day (24 hours) – see Overdose warninguse dose cup or tablespoonadults & children 12 yrs & overOne Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor. Marketed by Fred's, Inc., this product is identified by NDC 55315-003 and is authorized under FDA application part338.

Identification & Billing

NDC Package Code
55315-003-12
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
55315-003
11-Digit Billing Format
55315000312
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nighttime Sleep Aid
Dosage Form
-
Usage Information
Take only one dose per day (24 hours) – see Overdose warninguse dose cup or tablespoonadults & children 12 yrs & overOne Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

Regulatory & Marketing

Labeler Name
Fred's, Inc.
FDA Application #
part338
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-23-2013
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55315-003-12 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Nighttime Sleep Aid, labeled by Fred's, Inc.. 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 Fred's, Inc. on October 23, 2013. The current certification is valid through December 31, 2017.

How is this Fred's, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55315000312. 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)
55315-003-12
11-Digit CMS (5-4-2)
55315-0003-12

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