Suvorexant Tablet, Film Coated
NDC Package 67651-0385-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Suvorexant tablets is a medication used to treat a certain sleep problem (insomnia). This formulation utilizes a tablet, film coated delivery system. Marketed by Patheon Pharmaceuticals Inc., this product is identified by NDC 67651-0385.

Identification & Billing

NDC Package Code
67651-0385-0
Package Description
116000 TABLET, FILM COATED in 1 DRUM
Product Code
67651-0385
11-Digit Billing Format
67651038500

Clinical Specifications

Proprietary Name
Suvorexant
Non-Proprietary Name
Suvorexant
Substance Name
Suvorexant
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.
Active Ingredient(s)
SUVOREXANT 20 mg/1
Usage Information
This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep and stay asleep longer, so you can get a better night's rest. Suvorexant belongs to a class of drugs known as sedative-hypnotics. If your insomnia continues for longer than 7 to 10 days after starting treatment, talk to your doctor to see if you need other treatment.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Patheon Pharmaceuticals Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-20-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 67651-0385-0 identifies a specific commercial package of 116000 tablet, film coated in 1 drum of Suvorexant (UNFINISHED drug), drug for further processing labeled by Patheon Pharmaceuticals Inc.. This tablet, film coated is formulated for use and contains suvorexant 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 Patheon Pharmaceuticals Inc. on January 20, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain sleep problem (insomnia). It may help you fall asleep and stay asleep longer, so you can get a better night's rest. Suvorexant belongs to a class of drugs known as sedative-hypnotics. If your insomnia continues for longer than 7 to 10 days after starting treatment, talk to your doctor to see if you need other treatment.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67651038500. 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)
67651-0385-0
11-Digit CMS (5-4-2)
67651-0385-00

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