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  5. NDC Package Code: 69539-058-34 Asenapine

NDC Package 69539-058-34 Asenapine

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
69539-058-34
Package Description:
60 TABLET in 1 BOX
Product Code:
69539-058
Proprietary Name:
Asenapine
Non-Proprietary Name:
Asenapine Maleate
Substance Name:
Asenapine Maleate
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).
11-Digit NDC Billing Format:
69539005834
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:
    Msn Laboratories Private 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):
  • ASENAPINE MALEATE 5 mg/1
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA205960
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-27-2021
    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.

    Frequently Asked Questions

    What is NDC 69539-058-34?

    The NDC Packaged Code 69539-058-34 is assigned to a package of 60 tablet in 1 box of Asenapine, a human prescription drug labeled by Msn Laboratories Private Limited. The product's dosage form is tablet and is administered via sublingual form.

    Is NDC 69539-058 included in the NDC Directory?

    Yes, Asenapine with product code 69539-058 is active and included in the NDC Directory. The product was first marketed by Msn Laboratories Private Limited on August 27, 2021 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 69539-058-34?

    The 11-digit format is 69539005834. 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
    5-3-269539-058-345-4-269539-0058-34