Zolpidem Tartrate Tablet
NDC Package 62135-779-90

11-digit billing NDC: 62135077990 · Billing unit: EA · 90 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zolpidem Tartrate tablets is zolpidem tartrate is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.  Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)]. This formulation utilizes a tablet delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-779 and is authorized under FDA application ANDA077388.

Identification & Billing

NDC Package Code
62135-779-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
62135-779
11-Digit Billing Format
62135077990
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zolpidem Tartrate
Non-Proprietary Name
Zolpidem Tartrate
Substance Name
Zolpidem Tartrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZOLPIDEM TARTRATE 10 mg/1
Pharmacologic Class
Usage Information
Zolpidem tartrate is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.  Zolpidem tartrate 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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077388
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2024
Listing Expiration
12-31-2027
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 62135-779-90 identifies a specific commercial package of 90 tablet in 1 bottle of Zolpidem Tartrate, a human prescription drug labeled by Chartwell Rx, Llc. This tablet is formulated for oral use and contains zolpidem tartrate 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 Chartwell Rx, Llc on August 27, 2024. The current certification is valid through December 31, 2027.

How is this Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135077990. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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 (5-3-2)
62135-779-90
11-Digit CMS (5-4-2)
62135-0779-90

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