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  5. NDC Package Code: 42291-560-90 Midodrine Hydrochloride

NDC Package 42291-560-90 Midodrine Hydrochloride

Tablet 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:
42291-560-90
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
42291-560
Proprietary Name:
Midodrine Hydrochloride
Non-Proprietary Name:
Midodrine Hydrochloride
Substance Name:
Midodrine Hydrochloride
Usage Information:
Midodrine hydrochloride is indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride.After initiation of treatment, midodrine hydrochloride should be continued only for patients who report significant symptomatic improvement.
11-Digit NDC Billing Format:
42291056090
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: 993462 - midodrine HCl 10 MG Oral Tablet
  • RxCUI: 993462 - midodrine hydrochloride 10 MG Oral Tablet
  • RxCUI: 993466 - midodrine HCl 2.5 MG Oral Tablet
  • RxCUI: 993466 - midodrine hydrochloride 2.5 MG Oral Tablet
  • RxCUI: 993470 - midodrine HCl 5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Avkare
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MIDODRINE HYDROCHLORIDE 2.5 mg/1
    • Pharmacologic Class(es):
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077746
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-05-2017
    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 42291-560-90?

    The NDC Packaged Code 42291-560-90 is assigned to a package of 90 tablet in 1 bottle of Midodrine Hydrochloride, a human prescription drug labeled by Avkare. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package.

    Is NDC 42291-560 included in the NDC Directory?

    Yes, Midodrine Hydrochloride with product code 42291-560 is active and included in the NDC Directory. The product was first marketed by Avkare on May 05, 2017 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 42291-560-90?

    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 42291-560-90?

    The 11-digit format is 42291056090. 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
    5-3-242291-560-905-4-242291-0560-90