Asenapine Tablet
NDC Package 42794-017-08

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

Asenapine tablets is asenapine sublingual tablet(s) is indicated for:Bipolar I disorder  [see Clinical Studies ( 14.2)] Adjunctive treatment to lithium or valproate in adults. This formulation utilizes a tablet delivery system. Marketed by Sigmapharm Laboratories, Llc, this product is identified by NDC 42794-017 and is authorized under FDA application ANDA206107.

Identification & Billing

NDC Package Code
42794-017-08
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
42794-017
11-Digit Billing Format
42794001708
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Asenapine
Non-Proprietary Name
Asenapine
Substance Name
Asenapine
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 10 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Asenapine sublingual tablet(s) is indicated for:Bipolar I disorder  [see Clinical Studies ( 14.2)] Adjunctive treatment to lithium or valproate in adults

Regulatory & Marketing

Labeler Name
Sigmapharm Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA206107
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-14-2020
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 (42794-017). Click a package code to view its specific billing and regulatory data.

42794-017-10
60 TABLET in 1 BOTTLE, PLASTIC
42794-017-22
10 TABLET in 1 BOTTLE, PLASTIC

* 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 42794-017-08 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Asenapine, a human prescription drug labeled by Sigmapharm Laboratories, Llc. This tablet is formulated for sublingual use and contains asenapine 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 Sigmapharm Laboratories, Llc on December 14, 2020. The current certification is valid through December 31, 2026.

How is this Sigmapharm Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42794001708. 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)
42794-017-08
11-Digit CMS (5-4-2)
42794-0017-08

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