Nortriptyline

Overview

Nortriptyline hydrochloride, the active metabolite of amitriptyline, is a tricyclic antidepressant (TCA). It is used in the treatment of major depression and is also used off-label for chronic pain and other conditions.

Indication

Nortriptyline is indicated for the relief of the symptoms of major depressive disorder (MDD). Some off-label uses for this drug include treatment of chronic pain, myofascial pain, neuralgia, and irritable bowel syndrome.

Associated Conditions

Chronic Pain
Irritable Bowel Syndrome (IBS)
Major Depressive Disorder (MDD)
Myofascial Pain Syndrome
Pain, Orofacial
Postherpetic Neuralgia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Management of Acute Tinnitus With Migraine Medications	2025/01/29	NCT06799169	Phase 4	Recruiting	University of California, Irvine
Treatment of Meniere's Disease With Migraine Medications	2022/10/17	NCT05582837	Phase 4	Recruiting	University of California, Irvine
RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT)	2022/09/08	NCT05531591	Phase 4	Completed	Centre for Addiction and Mental Health
Treatment of Tinnitus With Migraine Medications	2020/05/27	NCT04404439	Phase 4	Recruiting	University of California, Irvine
Pediatric Concussion Outcomes	2020/01/13	NCT04226365	Phase 4	Terminated	Lancaster General Hospital
Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments	2019/02/18	NCT03844412	Phase 2	Completed	Duke University
Nortriptyline for the Treatment of Functional Dyspepsia	2018/08/29	NCT03652571	Phase 3	Terminated	Maastricht University Medical Center
Antidepressants Trial in Parkinson's Disease	2018/08/29	NCT03652870	Phase 3	Completed	University College, London
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults	2016/11/10	NCT02960763	Phase 4	Completed	Washington University School of Medicine
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode	2016/09/28	NCT02918097	Phase 4	Completed	Federal University of Rio Grande do Sul

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nortriptyline Hydrochloride	AvPAK	50268-603	ORAL	10 mg in 1 1	1/8/2024
NORTRIPTYLINE HYDROCHLORIDE	DIRECT RX	72189-177	ORAL	50 mg in 1 1	2/9/2021
Nortriptyline Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	51672-4002	ORAL	25 mg in 1 1	5/4/2020
Nortriptyline Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	70710-1155	ORAL	50 mg in 1 1	3/27/2024
NORTRIPTYLINE HCI	Direct_Rx	61919-285	ORAL	25 mg in 1 1	10/5/2022
Nortriptyline Hydrochloride	Taro Pharmaceuticals U.S.A., Inc.	51672-4003	ORAL	50 mg in 1 1	5/4/2020
Nortriptyline HCL	Direct_Rx	61919-742	ORAL	50 mg in 1 1	3/11/2019
Nortriptyline Hydrochloride	Proficient Rx LP	63187-322	ORAL	10 mg in 1 1	1/1/2019
Nortriptyline Hydrochloride	A-S Medication Solutions	50090-1323	ORAL	50 mg in 1 1	5/4/2020
Nortriptyline Hydrochloride	Proficient Rx LP	71205-254	ORAL	25 mg in 1 1	6/1/2022

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
APO-NORTRIPTYLINE CAPSULE 10 mg	APOTEX INC	SIN09255P	CAPSULE	10 mg	3/18/1997
APO-NORTRIPTYLINE CAPSULE 25 mg	APOTEX INC	SIN09253P	CAPSULE	25 mg	3/18/1997

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
NORTRIPTYLINE MEDSURGE nortriptyline (as hydrochloride) 25 mg tablet blister pack	405312	Medsurge Pharma Pty Ltd	Medicine	A	1/30/2024
NORTRIPTYLINE MEDICIANZ nortriptyline (as hydrochloride) 10 mg tablet blister pack	405311	Medsurge Pharma Pty Ltd	Medicine	A	1/30/2024
NORTRIPTIMED nortriptyline (as hydrochloride) 25 mg tablet blister pack	405315	Medsurge Pharma Pty Ltd	Medicine	A	1/30/2024
NortriTABS nortriptyline (as hydrochloride) 10 mg uncoated tablet blister pack	220998	Amdipharm Mercury Australia Pty Ltd	Medicine	A	4/2/2015
ALLEGRON nortriptyline (as hydrochloride) 10mg tablet blister pack	14619	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/5/1991
NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet bottle	220985	Amdipharm Mercury Australia Pty Ltd	Medicine	A	4/2/2015
NORTRIPTYLINE MEDSURGE nortriptyline (as hydrochloride) 10 mg tablet blister pack	405314	Medsurge Pharma Pty Ltd	Medicine	A	1/30/2024
Nortriptyline Tablets 25 mg blister pack	153544	Alphapharm Pty Ltd	Medicine	A	7/9/2008
NORTRIPTYLINE MEDICIANZ nortriptyline (as hydrochloride) 25 mg tablet blister pack	405313	Medsurge Pharma Pty Ltd	Medicine	A	1/30/2024
NortriTABS nortriptyline (as hydrochloride) 10 mg uncoated tablet bottle	221001	Amdipharm Mercury Australia Pty Ltd	Medicine	A	4/2/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DOM-NORTRIPTYLINE 10MG CAPSULES	dominion pharmacal	02178729	Capsule - Oral	10 MG	10/1/1995
DOM-NORTRIPTYLINE 25MG CAPSULES	dominion pharmacal	02178737	Capsule - Oral	25 MG	10/1/1995

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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