Intermezzo
NDC Package 67213-175-31

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Intermezzo is a medication used to treat a certain type of sleep problem (insomnia) in adults who have trouble falling back asleep after waking up in the middle of the night. Marketed by Transcept Pharmaceuticals, Inc., this product is identified by NDC 67213-175 and is authorized under FDA application NDA022328.

Identification & Billing

NDC Package Code
67213-175-31
Package Description
30 POUCH in 1 CARTON / 1 TABLET in 1 POUCH (67213-175-01)
Product Code
67213-175
11-Digit Billing Format
67213017531

Clinical Specifications

Proprietary Name
Intermezzo
Dosage Form
-
Usage Information
This medication is used to treat a certain type of sleep problem (insomnia) in adults who have trouble falling back asleep after waking up in the middle of the night. It helps you return to sleep 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 should only be taken if you have at least 4 hours of bedtime left. Zolpidem is usually limited to short treatment periods of 1 to 2 weeks or less.

Regulatory & Marketing

Labeler Name
Transcept Pharmaceuticals, Inc.
FDA Application #
NDA022328
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-01-2012
End Marketing Date
04-04-2012
Listing Expiration
04-04-2012
Exclude Flag
D
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 67213-175-31 identifies a specific commercial package of 30 pouch in 1 carton / 1 tablet in 1 pouch (67213-175-01) of Intermezzo, labeled by Transcept Pharmaceuticals, Inc.. 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 Transcept Pharmaceuticals, Inc. on April 01, 2012. The current certification is valid through April 04, 2012.

What are the primary indications for this medication?

This medication is used to treat a certain type of sleep problem (insomnia) in adults who have trouble falling back asleep after waking up in the middle of the night. It helps you return to sleep 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 should only be taken if you have at least 4 hours of bedtime left. Zolpidem is usually limited to short treatment periods of 1 to 2 weeks or less.

How is this Transcept Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67213017531. 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)
67213-175-31
11-Digit CMS (5-4-2)
67213-0175-31

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