Saphris
NDC Package 0052-2139-04

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

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

Saphris is a medication used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder). Marketed by Merck Sharp & Dohme Corp, this product is identified by NDC 0052-2139 and is authorized under FDA application NDA022117.

Identification & Billing

NDC Package Code
0052-2139-04
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code
0052-2139
11-Digit Billing Format
00052213904
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA

Clinical Specifications

Proprietary Name
Saphris
Dosage Form
-
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
Merck Sharp & Dohme Corp
FDA Application #
NDA022117
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-21-2010
End Marketing Date
12-31-2021
Listing Expiration
12-31-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0052-2139). Click a package code to view its specific billing and regulatory data.

0052-2139-02
2 CASE in 1 CARTON / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK
0052-2139-03
6 CASE in 1 CARTON / 1 BLISTER PACK in 1 CASE / 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 0052-2139-04 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack of Saphris, labeled by Merck Sharp & Dohme Corp. 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 Merck Sharp & Dohme Corp on June 21, 2010. The current certification is valid through December 31, 2021.

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 Merck Sharp & Dohme Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00052213904. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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)
0052-2139-04
11-Digit CMS (5-4-2)
00052-2139-04

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