Ambien Tablet, Coated
NDC Package 0024-5521-10

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ambien (zolpidem tartrate) tablets is zolpidem is used to treat a certain sleep problem (insomnia) in adults. This formulation utilizes a tablet, coated delivery system. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0024-5521 and is authorized under FDA application NDA021774.

Identification & Billing

NDC Package Code
0024-5521-10
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK
Product Code
0024-5521
11-Digit Billing Format
00024552110
RxNorm Crosswalk
  • RxCUI: 854880 - zolpidem tartrate 12.5 MG Extended Release Oral Tablet
  • RxCUI: 854882 - AMBIEN CR 12.5 MG Extended Release Oral Tablet
  • RxCUI: 854882 - zolpidem tartrate 12.5 MG Extended Release Oral Tablet [Ambien]
  • RxCUI: 854882 - Ambien CR 12.5 MG Extended Release Oral Tablet
  • RxCUI: 854894 - zolpidem tartrate 6.25 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Ambien CR
Non-Proprietary Name
Zolpidem Tartrate
Substance Name
Zolpidem Tartrate
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZOLPIDEM TARTRATE 12.5 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
Sanofi-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021774
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-19-2005
End Marketing Date
07-31-2026
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 (0024-5521). Click a package code to view its specific billing and regulatory data.

0024-5521-31
100 TABLET, COATED in 1 BOTTLE
0024-5521-50
500 TABLET, 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 0024-5521-10 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, coated in 1 blister pack of Ambien CR, a human prescription drug labeled by Sanofi-aventis U.s. Llc. This tablet, 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 Sanofi-aventis U.s. Llc on September 19, 2005.

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 Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00024552110. 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 (4-4-2)
0024-5521-10
11-Digit CMS (5-4-2)
00024-5521-10

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