Nightime Sleep Aid
NDC Package 58805-006-01

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

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

Nightime Sleep Aid is adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.children under 12 years:do not use. Marketed by Agile Pharmachem, this product is identified by NDC 58805-006 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
58805-006-01
Package Description
750 BAG in 1 BOX / 30 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
58805-006
11-Digit Billing Format
58805000601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nightime Sleep Aid
Dosage Form
-
Usage Information
Adults and children 12 years and over : one softgel (50 mg) at bed time if needed or as directed by a doctor.children under 12 years:do not use

Regulatory & Marketing

Labeler Name
Agile Pharmachem
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
03-31-2014
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 (58805-006). Click a package code to view its specific billing and regulatory data.

58805-006-00
750 BAG in 1 BOX / 1 CAPSULE, LIQUID FILLED in 1 BAG
58805-006-02
750 BOX in 1 BAG / 48 CAPSULE, LIQUID FILLED in 1 BOX

* 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 58805-006-01 identifies a specific commercial package of 750 bag in 1 box / 30 capsule, liquid filled in 1 bag of Nightime Sleep Aid, labeled by Agile Pharmachem. 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 Agile Pharmachem on March 31, 2014. The current certification is valid through December 31, 2019.

How is this Agile Pharmachem product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58805000601. 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)
58805-006-01
11-Digit CMS (5-4-2)
58805-0006-01

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