Asenapine Tablet
NDC Package 69539-059-34

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

Package Information

Asenapine (asenapine 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 Msn Laboratories Private Limited, this product is identified by NDC 69539-059 and is authorized under FDA application ANDA205960.

Identification & Billing

NDC Package Code
69539-059-34
Package Description
60 TABLET in 1 BOX
Product Code
69539-059
11-Digit Billing Format
69539005934
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Asenapine
Non-Proprietary Name
Asenapine Maleate
Substance Name
Asenapine Maleate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
ASENAPINE MALEATE 10 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
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
Msn Laboratories Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205960
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-27-2021
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69539-059-34 identifies a specific commercial package of 60 tablet in 1 box of Asenapine, a human prescription drug labeled by Msn Laboratories Private Limited. This tablet is formulated for sublingual 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 Msn Laboratories Private Limited on August 27, 2021. The current certification is valid through December 31, 2026.

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 Msn Laboratories Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69539005934. 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)
69539-059-34
11-Digit CMS (5-4-2)
69539-0059-34

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