Midodrine Hydrochloride Tablet
NDC Package 85293-005-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Midodrine Hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). This formulation utilizes a tablet delivery system. Marketed by Umasuto, Llc, this product is identified by NDC 85293-005 and is authorized under FDA application ANDA207613.

Identification & Billing

NDC Package Code
85293-005-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
85293-005
11-Digit Billing Format
85293000501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Midodrine Hydrochloride
Non-Proprietary Name
Midodrine Hydrochloride
Substance Name
Midodrine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MIDODRINE HYDROCHLORIDE 2.5 mg/1
Pharmacologic Class
Usage Information
Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets 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 tablets'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.

Regulatory & Marketing

Labeler Name
Umasuto, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA207613
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-05-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 85293-005-01 identifies a specific commercial package of 100 tablet in 1 bottle of Midodrine Hydrochloride, a human prescription drug labeled by Umasuto, Llc. This tablet is formulated for oral use and contains midodrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Umasuto, Llc on March 05, 2025. The current certification is valid through December 31, 2026.

How is this Umasuto, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85293000501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
85293-005-01
11-Digit CMS (5-4-2)
85293-0005-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.