Ambien Cr
NDC Package 54868-5461-0

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.

Ambien Cr is zolpidem is used to treat a certain sleep problem (insomnia) in adults. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5461 and is authorized under FDA application NDA021774.

Identification & Billing

NDC Package Code
54868-5461-0
Package Description
10 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
54868-5461
11-Digit Billing Format
54868546100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
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
Dosage Form
-
Usage Information
Zolpidem is used to treat a certain sleep problem (insomnia) in adults. It helps you fall asleep faster and stay asleep longer, so you can get a better night's sleep. It may also reduce the number of times you wake up during the night. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021774
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-07-2005
Listing Expiration
12-31-2017
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 (54868-5461). Click a package code to view its specific billing and regulatory data.

54868-5461-1
30 TABLET, COATED in 1 BOTTLE, PLASTIC

* 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 54868-5461-0 identifies a specific commercial package of 10 tablet, coated in 1 bottle, plastic of Ambien Cr, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 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 Physicians Total Care, Inc. on October 07, 2005. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Zolpidem is used to treat a certain sleep problem (insomnia) in adults. It helps you fall asleep faster and stay asleep longer, so you can get a better night's sleep. It may also reduce the number of times you wake up during the night. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868546100. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
54868-5461-0
11-Digit CMS (5-4-2)
54868-5461-00

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