Zolpidem
NDC Package 50436-0009-2

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.

Zolpidem is tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Marketed by Unit Dose Services, this product is identified by NDC 50436-0009 and is authorized under FDA application ANDA077214.

Identification & Billing

NDC Package Code
50436-0009-2
Package Description
60 TABLET in 1 BOTTLE
Product Code
50436-0009
11-Digit Billing Format
50436000902
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
RxCUI: 854876 - zolpidem tartrate 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Zolpidem
Dosage Form
-
Usage Information
Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA077214
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-24-2020
Listing Expiration
12-31-2023
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 (50436-0009). Click a package code to view its specific billing and regulatory data.

50436-0009-1
30 TABLET in 1 BOTTLE

* 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 50436-0009-2 identifies a specific commercial package of 60 tablet in 1 bottle of Zolpidem, labeled by Unit Dose Services. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Unit Dose Services on September 24, 2020. The current certification is valid through December 31, 2023.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436000902. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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 (5-4-1)
50436-0009-2
11-Digit CMS (5-4-2)
50436-0009-02

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