1. Home
  2. Labeler Index
  3. Ncs Healthcare Of Ky, Llc Dba Vangard Labs
  4. 0615-8443
  5. NDC Package Code: 0615-8443-39 Midodrine Hydrochloride

NDC Package 0615-8443-39 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:
0615-8443-39
Package Description:
30 TABLET in 1 BLISTER PACK
Product Code:
0615-8443
Proprietary Name:
Midodrine Hydrochloride
Non-Proprietary Name:
Midodrine Hydrochloride
Substance Name:
Midodrine Hydrochloride
Usage Information:
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablet scan 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’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 tablets, 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 tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.
11-Digit NDC Billing Format:
00615844339
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:
    Ncs Healthcare Of Ky, Llc Dba Vangard Labs
    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:
    ANDA214734
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-22-2021
    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 0615-8443-39?

    The NDC Packaged Code 0615-8443-39 is assigned to a package of 30 tablet in 1 blister pack of Midodrine Hydrochloride, a human prescription drug labeled by Ncs Healthcare Of Ky, Llc Dba Vangard Labs. The product's dosage form is tablet and is administered via oral form.

    Is NDC 0615-8443 included in the NDC Directory?

    Yes, Midodrine Hydrochloride with product code 0615-8443 is active and included in the NDC Directory. The product was first marketed by Ncs Healthcare Of Ky, Llc Dba Vangard Labs on January 22, 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 0615-8443-39?

    The 11-digit format is 00615844339. 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
    4-4-20615-8443-395-4-200615-8443-39