NDC Package 42794-017-10 Asenapine

Tablet Sublingual - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
42794-017-10
Package Description:
60 TABLET in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Asenapine
Non-Proprietary Name:
Asenapine
Substance Name:
Asenapine
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
11-Digit NDC Billing Format:
42794001710
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 859975 - asenapine 10 MG Sublingual Tablet
  • RxCUI: 859975 - asenapine (as asenapine maleate) 10 MG Sublingual Tablet
  • RxCUI: 859981 - asenapine 5 MG Sublingual Tablet
  • RxCUI: 859981 - asenapine (as asenapine maleate) 5 MG Sublingual Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sigmapharm Laboratories, Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Sublingual - Administration beneath the tongue.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA206107
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-14-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    42794-017-0830 TABLET in 1 BOTTLE, PLASTIC
    42794-017-2210 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 42794-017-10?

    The NDC Packaged Code 42794-017-10 is assigned to a package of 60 tablet in 1 bottle, plastic of Asenapine, a human prescription drug labeled by Sigmapharm Laboratories, Llc. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 42794-017 included in the NDC Directory?

    Yes, Asenapine with product code 42794-017 is active and included in the NDC Directory. The product was first marketed by Sigmapharm Laboratories, Llc on December 14, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 42794-017-10?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 60.

    What is the 11-digit format for NDC 42794-017-10?

    The 11-digit format is 42794001710. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-242794-017-105-4-242794-0017-10