Zolpidem Tartrate Tablet, Film Coated
NDC Package 72722-103-07

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

Zolpidem Tartrate tablets is zolpidem is used to treat a certain sleep problem (insomnia) in adults. This formulation utilizes a tablet, film coated delivery system. Marketed by The Acme Laboratories Ltd., this product is identified by NDC 72722-103 and is authorized under FDA application ANDA077214.

Identification & Billing

NDC Package Code
72722-103-07
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
72722-103
11-Digit Billing Format
72722010307
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zolpidem Tartrate
Non-Proprietary Name
Zolpidem Tartrate
Substance Name
Zolpidem Tartrate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZOLPIDEM TARTRATE 5 mg/1
Pharmacologic Class
Usage Information
Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
The Acme Laboratories Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA077214
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-24-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72722-103). Click a package code to view its specific billing and regulatory data.

72722-103-01
30 TABLET, FILM COATED in 1 BOTTLE
72722-103-05
100 TABLET, FILM COATED 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 72722-103-07 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Zolpidem Tartrate, a human prescription drug labeled by The Acme Laboratories Ltd.. This tablet, film coated 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 The Acme Laboratories Ltd. on September 24, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night's rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.

How is this The Acme Laboratories Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72722010307. 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)
72722-103-07
11-Digit CMS (5-4-2)
72722-0103-07

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