Asenaprine Maleate Tablet
NDC Package 62938-0039-3

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.

Asenaprine Maleate tablets is a medication used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). This formulation utilizes a tablet delivery system. Marketed by Catalent U.k. Swindon Zydis Limited, this product is identified by NDC 62938-0039.

Identification & Billing

NDC Package Code
62938-0039-3
Package Description
2565 BLISTER PACK in 1 BOX / 10 TABLET in 1 BLISTER PACK
Product Code
62938-0039
11-Digit Billing Format
62938003903

Clinical Specifications

Proprietary Name
Asenaprine Maleate
Non-Proprietary Name
Asenaprine Maleate
Substance Name
Asenapine Maleate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
ASENAPINE MALEATE 2.5 mg/1
Usage Information
This medication is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Asenapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there) and prevent severe mood swings. Asenapine is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

Regulatory & Marketing

Labeler Name
Catalent U.k. Swindon Zydis Limited
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
02-24-2020
Listing Expiration
12-31-2027
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 62938-0039-3 identifies a specific commercial package of 2565 blister pack in 1 box / 10 tablet in 1 blister pack of Asenaprine Maleate (UNFINISHED drug), drug for further processing labeled by Catalent U.k. Swindon Zydis Limited. This tablet is formulated for use and contains asenapine maleate 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 Catalent U.k. Swindon Zydis Limited on February 24, 2020. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Asenapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there) and prevent severe mood swings. Asenapine is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

How is this Catalent U.k. Swindon Zydis Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62938003903. 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)
62938-0039-3
11-Digit CMS (5-4-2)
62938-0039-03

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