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  5. NDC Package Code: 0615-7768-39 Isosorbide Mononitrate

NDC Package 0615-7768-39 Isosorbide Mononitrate

Tablet, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0615-7768-39
Package Description:
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code:
0615-7768
Proprietary Name:
Isosorbide Mononitrate
Non-Proprietary Name:
Isosorbide Mononitrate
Substance Name:
Isosorbide Mononitrate
Usage Information:
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease). This medication belongs to a class of drugs known as nitrates. It works by relaxing and widening blood vessels so blood can flow more easily to the heart. This medication will not relieve chest pain once it occurs. Also, it is not intended to be taken just before physical activities (such as exercise or sexual intercourse) to prevent chest pain. Other medications may be prescribed by your doctor for these conditions. Consult your doctor for more details.
11-Digit NDC Billing Format:
00615776839
NDC to RxNorm Crosswalk:
  • RxCUI: 353538 - isosorbide mononitrate 60 MG 24HR Extended Release Oral Tablet
  • RxCUI: 353538 - 24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet
  • RxCUI: 353538 - isosorbide mononitrate 60 MG 24 HR Extended Release Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Ncs Healthcare Of Ky, Llc Dba Vangard Labs
    Dosage Form:
    Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ISOSORBIDE MONONITRATE 60 mg/1
    • Pharmacologic Class(es):
  • Nitrate Vasodilator - [EPC] (Established Pharmacologic Class)
  • Nitrates - [CS]
  • Vasodilation - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    ANDA200495
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-03-2011
    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
    0615-7768-0515 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0615-7768-39?

    The NDC Packaged Code 0615-7768-39 is assigned to a package of 30 tablet, extended release in 1 blister pack of Isosorbide Mononitrate, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The product's dosage form is tablet, extended release and is administered via oral form.

    Is NDC 0615-7768 included in the NDC Directory?

    Yes, Isosorbide Mononitrate with product code 0615-7768 is active and included in the NDC Directory. The product was first marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs on June 03, 2011 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 0615-7768-39?

    The 11-digit format is 00615776839. 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 4-4-2 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
    4-4-20615-7768-395-4-200615-7768-39