Quick answers
- What is Midodrine hydrochloride used for?
- The FDA-approved label (Midodrine Hydrochloride, Par Health USA, LLC, August 20, 2026) says: “Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Midodrine hydrochloride have a boxed warning?
- The label we quote has no boxed warning, but 45 of 48 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Midodrine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Midodrine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started February 17, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Midodrine hydrochloride?
- 33 companies list prescription products of Midodrine hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Major Pharmaceuticals and Cardinal Health 107, LLC.
What Midodrine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Midodrine hydrochloride tablets, USP are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets, USP 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 …
— FDA label: Midodrine Hydrochloride, Par Health USA, LLC, effective August 20, 2026. Read the full label on DailyMed →
The FDA has 48 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
45 of 48 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 109 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| midodrine hydrochloride 10 mg tablet | Generic | $0.1463 per tablet |
| midodrine hydrochloride 2.5 mg tablet | Generic | $0.0773 per tablet |
| midodrine hydrochloride 5 mg tablet | Generic | $0.1070 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack15 products
- Major Pharmaceuticals6 products
- Cardinal Health 107, LLC4 products
- Proficient Rx LP3 products
- NorthStar RxLLC3 products
- Umasuto, LLC3 products
- Avet Pharmaceuticals Inc.3 products
- AvKARE3 products
- Alembic Pharmaceuticals Inc.3 products
- Zydus Lifesciences Limited3 products
- NorthStar Rx LLC3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- First Nation Group, LLC3 products
- Par Health USA, LLC3 products
- Golden State Medical Supply, Inc.3 products
- Apotex Corp.3 products
- American Health Packaging3 products
- Upsher-Smith Laboratories, LLC3 products
- Rising Pharma Holdings, Inc.3 products
- Novugen Pharma (USA) LLC3 products
- TruPharma, LLC3 products
- Aurobindo Pharma Limited3 products
- Advagen Pharma Limited3 products
- AvPAK3 products
- Mylan Pharmaceuticals Inc.3 products
- Lifestar Pharma LLC3 products
- Alembic Pharmaceuticals Limited3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Xiromed, LLC3 products
- Coupler LLC1 product
- Mylan Institutional Inc.1 product
- Safecor Health LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (12)
- ANDA076577Mylan Pharms Inc · September 10, 2003
- ANDA076725Beijing Yiling · November 3, 2004
- ANDA077746Apotex · September 12, 2006
- ANDA207169Ph Health · October 29, 2018
- ANDA207613Unique · November 2, 2018
- ANDA212543Rubicon Research · August 19, 2019
- ANDA212774Aurobindo Pharma Ltd · August 10, 2020
- ANDA213055Zydus Lifesciences · September 1, 2020
- ANDA207849Xiromed · October 1, 2020
- ANDA214734Alembic · January 21, 2021
- ANDA211973Novugen · October 17, 2023
- ANDA217271Mankind Pharma · November 1, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 17, 2026 · Class II · Ongoing · D-0383-2026
Defective container; inadequately sealed blister packaging.
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. — The Harvard Drug Group LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 993462, 993466, 993470 |
|---|---|
| SPL set ID of the quoted label | 863f12bd-d4a9-4547-8667-5dfa9e2ce6d1 |
| FDA labels (SPL) | 48 |
| FDA applications | 12 ANDA |
| Active ingredients (FDA) | MIDODRINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Midodrine Hydrochloride, Par Health USA, LLC, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →