Midodrine

Generic Name: Midodrine

Brand Names: Proamatine

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₁₈N_₂O_₄

CAS Number: 42794-76-3

Unique Ingredient Identifier: 6YE7PBM15H

Overview

An ethanolamine derivative that is an adrenergic alpha agonist. It is used as a vasoconstrictor agent in the treatment of hypotension.

Indication

For the treatment of symptomatic orthostatic hypotension (OH).

Associated Conditions

Symptomatic Orthostatic Hypotension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension	2024/05/08	NCT06405555	Phase 2	Not yet recruiting	Ottawa Heart Institute Research Corporation
Use of Midodrine in Septic Shock Patients	2024/03/20	NCT06319248	Phase 2	Recruiting	Mayo Clinic
Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.	2024/02/07	NCT06245590	Not Applicable	Not yet recruiting	Institute of Liver and Biliary Sciences, India
Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial	2024/01/19	NCT06213935	Not Applicable	Not yet recruiting	Sohag University
Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites	2023/10/19	NCT06091345	Not Applicable	Recruiting	Institute of Liver and Biliary Sciences, India
Treatment of Orthostatic Hypotension in SCI	2023/05/03	NCT05839652	Phase 4	Recruiting	James J. Peters Veterans Affairs Medical Center
Treatment Strategy of Vasovagal Syncope	2023/04/07	NCT05803148	Not Applicable	Recruiting	China National Center for Cardiovascular Diseases
Midodrine Effect on the Mortality Rates in Septic Shock Patients	2023/03/21	NCT05778838	Phase 2	Completed	Noha Mansour
Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population	2022/09/22	NCT05548985	Not Applicable	Completed	Cairo University
To Assess the Efficacy of Midodrine in Prevention of Cirrhosis Related Complications in Children Awaiting Liver Transplantation.	2022/03/18	NCT05287100	Not Applicable	Completed	Institute of Liver and Biliary Sciences, India

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Midodrine Hydrochloride	Novugen Pharma (USA) LLC	82293-004	ORAL	5 mg in 1 1	10/20/2023
Midodrine Hydrochloride	McKesson Corporation DBA SKY Packaging	63739-145	ORAL	5 mg in 1 1	12/13/2023
Midodrine Hydrochloride	Novugen Pharma (USA) LLC	82293-003	ORAL	2.5 mg in 1 1	10/20/2023
Midodrine Hydrochloride	Proficient Rx LP	71205-906	ORAL	10 mg in 1 1	4/1/2022
Midodrine Hydrochloride	Novugen Pharma (USA) LLC	82293-005	ORAL	10 mg in 1 1	10/20/2023
MIDODRINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8443	ORAL	2.5 mg in 1 1	8/8/2023
Midodrine Hydrochloride	Cardinal Health 107, LLC	55154-4174	ORAL	10 mg in 1 1	3/2/2023
MIDODRINE HYDROCHLORIDE	Carilion Materials Management	68151-2958	ORAL	5 mg in 1 1	1/28/2016
Midodrine hydrochloride	Zydus Lifesciences Limited	70771-1595	ORAL	2.5 mg in 1 1	11/1/2023
Midodrine Hydrochloride	Cardinal Health 107, LLC	55154-5696	ORAL	5 mg in 1 1	1/25/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
GUTRON TABLET 5 mg	Takeda GmbH (Oranienburg plant)	SIN11500P	TABLET	5 mg	4/28/2001

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MIDODRINE ANS midodrine hydrochloride 2.5 mg immediate release tablet blister pack	309181	Southern XP IP Pty Ltd	Medicine	A	12/18/2019
MIDODRINE ANS midodrine hydrochloride 5 mg immediate release tablet blister pack	309182	Southern XP IP Pty Ltd	Medicine	A	12/18/2019
VASODRINE midodrine hydrochloride 5 mg immediate release tablet blister pack	309184	Southern XP IP Pty Ltd	Medicine	A	12/18/2019
MIDODRINE SCP midodrine hydrochloride 5 mg immediate release tablet blister pack	309180	Southern XP IP Pty Ltd	Medicine	A	12/18/2019
Midodrine Hydrochloride 10 mg tablet bottle	387795	Alphapharm Pty Ltd	Medicine	A	5/3/2022
VASODRINE midodrine hydrochloride 2.5 mg immediate release tablet blister pack	309183	Southern XP IP Pty Ltd	Medicine	A	12/18/2019
Midodrine Hydrochloride 5 mg tablet bottle	387794	Alphapharm Pty Ltd	Medicine	A	5/3/2022
Midodrine Hydrochloride 2.5 mg tablet bottle	387793	Alphapharm Pty Ltd	Medicine	A	5/3/2022
MIDODRINE SCP midodrine hydrochloride 2.5 mg immediate release tablet blister pack	309179	Southern XP IP Pty Ltd	Medicine	A	12/18/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AMATINE	shire pharma canada ulc	01934406	Tablet - Oral	5 MG	12/31/1992
MIDODRINE	sanis health inc	02533219	Tablet - Oral	5 MG	5/31/2023
MAR-MIDODRINE	marcan pharmaceuticals inc	02473984	Tablet - Oral	2.5 MG	8/3/2018
APO-MIDODRINE	Apotex Inc	02278685	Tablet - Oral	5 MG	6/13/2006
MIDODRINE	sanis health inc	02533200	Tablet - Oral	2.5 MG	5/31/2023
M-MIDODRINE	mantra pharma inc	02547120	Tablet - Oral	5 MG	12/17/2024
JAMP MIDODRINE	Jamp Pharma Corporation	02517701	Tablet - Oral	2.5 MG	2/21/2022
MAR-MIDODRINE	marcan pharmaceuticals inc	02473992	Tablet - Oral	5 MG	8/3/2018
JAMP MIDODRINE	Jamp Pharma Corporation	02517728	Tablet - Oral	5 MG	2/21/2022
M-MIDODRINE	mantra pharma inc	02547112	Tablet - Oral	2.5 MG	10/23/2024

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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