Saphris Tablet
NDC Package 0456-2402-63

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

Saphris (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 Allergan, Inc., this product is identified by NDC 0456-2402 and is authorized under FDA application NDA022117.

Identification & Billing

NDC Package Code
0456-2402-63
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (0456-2402-11)
Product Code
0456-2402
11-Digit Billing Format
00456240263
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Saphris
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 2.5 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
Allergan, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022117
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-30-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0456-2402). Click a package code to view its specific billing and regulatory data.

0456-2402-10
1 CASE in 1 CARTON / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK
0456-2402-60
6 CASE in 1 CARTON / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACK

* 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 0456-2402-63 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack (0456-2402-11) of Saphris, a human prescription drug labeled by Allergan, Inc.. 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 Allergan, Inc. on December 30, 2014. 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 Allergan, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00456240263. 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 (4-4-2)
0456-2402-63
11-Digit CMS (5-4-2)
00456-2402-63

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