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  5. NDC Package Code: 52536-006-09 Isosorbide Dinitrate And Hydralazine Hydrochloride

NDC Package 52536-006-09 Isosorbide Dinitrate And Hydralazine Hydrochloride

Hydralazine Hydrochloride And Isosorbide Dinitrate Tablet, Film Coated Oral - 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:
52536-006-09
Package Description:
90 TABLET, FILM COATED in 1 BOTTLE
Product Code:
52536-006
Proprietary Name:
Isosorbide Dinitrate And Hydralazine Hydrochloride
Non-Proprietary Name:
Hydralazine Hydrochloride And Isosorbide Dinitrate
Substance Name:
Hydralazine Hydrochloride; Isosorbide Dinitrate
Usage Information:
Isosorbide dinitrate and hydralazine hydrochloride tablets are contraindicated in patients who are allergic to organic nitrates.Do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)].Do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension.
11-Digit NDC Billing Format:
52536000609
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
90 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 905377 - isosorbide dinitrate 20 MG / hydrALAZINE HCl 37.5 MG Oral Tablet
  • RxCUI: 905377 - hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral Tablet
  • RxCUI: 905377 - Hydralazine Hydrochloride 37.5 MG / ISDN 20 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Wilshire Pharmaceuticals
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HYDRALAZINE HYDROCHLORIDE 37.5 mg/1
  • ISOSORBIDE DINITRATE 20 mg/1
    • Pharmacologic Class(es):
  • Arteriolar Vasodilation - [PE] (Physiologic Effect)
  • Arteriolar Vasodilator - [EPC] (Established Pharmacologic Class)
  • Nitrate Vasodilator - [EPC] (Established Pharmacologic Class)
  • Nitrates - [CS]
  • Vasodilation - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    NDA020727
    Marketing Category:
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    04-15-2022
    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 52536-006-09?

    The NDC Packaged Code 52536-006-09 is assigned to a package of 90 tablet, film coated in 1 bottle of Isosorbide Dinitrate And Hydralazine Hydrochloride, a human prescription drug labeled by Wilshire Pharmaceuticals. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 52536-006 included in the NDC Directory?

    Yes, Isosorbide Dinitrate And Hydralazine Hydrochloride with product code 52536-006 is active and included in the NDC Directory. The product was first marketed by Wilshire Pharmaceuticals on April 15, 2022 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 52536-006-09?

    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 90.

    What is the 11-digit format for NDC 52536-006-09?

    The 11-digit format is 52536000609. 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
    5-3-252536-006-095-4-252536-0006-09