NDC Package 46708-199-31 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:
46708-199-31
Package Description:
100 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Code:
Proprietary Name:
Asenapine
Non-Proprietary Name:
Asenapine
Substance Name:
Asenapine
Usage Information:
 Asenapine is indicated for: • Bipolar I disorder [see Clinical Studies (14.2)]     •Adjunctive treatment to lithium or valproate in adults
11-Digit NDC Billing Format:
46708019931
NDC to RxNorm Crosswalk:
  • RxCUI: 1606337 - asenapine 2.5 MG Sublingual Tablet
  • RxCUI: 1606337 - asenapine (as asenapine maleate) 2.5 MG Sublingual Tablet
  • RxCUI: 859975 - asenapine 10 MG Sublingual Tablet
  • RxCUI: 859975 - asenapine (as asenapine maleate) 10 MG Sublingual Tablet
  • RxCUI: 859981 - asenapine 5 MG Sublingual Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alembic Pharmaceuticals Limited
    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:
    ANDA206098
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-10-2020
    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
    46708-199-6060 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (46708-199-10)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 46708-199-31?

    The NDC Packaged Code 46708-199-31 is assigned to a package of 100 blister pack in 1 carton / 10 tablet in 1 blister pack of Asenapine, a human prescription drug labeled by Alembic Pharmaceuticals Limited. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 46708-199 included in the NDC Directory?

    Yes, Asenapine with product code 46708-199 is active and included in the NDC Directory. The product was first marketed by Alembic Pharmaceuticals Limited on December 10, 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 11-digit format for NDC 46708-199-31?

    The 11-digit format is 46708019931. 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
    5-3-246708-199-315-4-246708-0199-31