Is Nortriptyline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Nortriptyline.

Is Nortriptyline approved by the US FDA?

Drugs@FDA lists 15 application product lines for Nortriptyline, including NORTRIPTYLINE HYDROCHLORIDE (Prescription); NORTRIPTYLINE HYDROCHLORIDE (Prescription); NORTRIPTYLINE HYDROCHLORIDE (Prescription); NORTRIPTYLINE HYDROCHLORIDE (Prescription); NORTRIPTYLINE HYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Nortriptyline?

US FDA: 1 entry (latest 2019-04-09).

Active substance

Nortriptyline

SFDA 6
US FDA 15
Health Canada 2
US price lines 5
NHS prices 5
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AVENTYL CAPSULES 10 MG	10 mg	Capsule · Oral use	100 Tablet Container	SAR 13.35	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
AVENTYL CAPSULES 10 MG	10 mg	Capsule · Oral use	25 Tablet Container	SAR 3.60	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
AVENTYL CAPSULES 25 MG	25 mg	Capsule · Oral use	100 Tablet Container	SAR 17.35	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
AVENTYL CAPSULES 25 MG	25 mg	Capsule · Oral use	25 Tablet Container	SAR 6.30	NCE · Prescription	Eli Lilly and Company	Withdrawn by MAH · Not Marketed
NORTRILEN TAB. 25 MG.	25 mg	Tablet · Oral use	100 Tablet Container	SAR 41.20	Generic · Prescription	H. LUNDBECK	Withdrawn by MAH · Not Marketed
NORTRILEN TAB. 25 MG.	25 mg	Tablet · Oral use	50 Tablet Container	SAR 15.45	Generic · Prescription	H. LUNDBECK	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE; EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE	capsule · oral	DR REDDYS LABS SA	Prescription	30 Mar 1992
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE	capsule · oral	TEVA	Prescription	27 Mar 1995
NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE; EQ 75MG BASE; EQ 25MG BASE; EQ 10MG BASE	capsule · oral	TARO	Prescription	8 May 2000
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	solution · oral	PHARM ASSOC	Prescription	23 Aug 2000
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	solution · oral	RUBICON RESEARCH	Prescription	15 Aug 2023
AVENTYL HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE	capsule · oral	LILLY	Discontinued	6 Nov 1964
AVENTYL	EQ 10MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	RANBAXY	Discontinued	6 Nov 1964
PAMELOR	EQ 10MG BASE/5ML	solution · oral	SPECGX LLC	Discontinued	1 Aug 1977
PAMELOR	EQ 10MG BASE; EQ 25MG BASE; EQ 75MG BASE; EQ 50MG BASE	capsule · oral	SPECGX LLC	Discontinued	1 Aug 1977
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE	capsule · oral	ANI PHARMS	Discontinued	31 Dec 1992
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE	capsule · oral	RISING	Discontinued	26 Jul 1993
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE	capsule · oral	TEVA	Discontinued	11 Apr 1996
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE	capsule · oral	AUROBINDO PHARMA LTD	Discontinued	30 Jun 1997
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE/5ML	solution · oral	TARO	Discontinued	20 Jun 2006
NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE; EQ 25MG BASE; EQ 50MG BASE; EQ 75MG BASE	capsule · oral	ZYDUS LIFESCIENCES	Discontinued	24 Feb 2021

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AVENTYL	00015229	10 MG	CAPSULE · ORAL	AA PHARMA INC
AVENTYL	00015237	25 MG	CAPSULE · ORAL	AA PHARMA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NORTRIPTYLINE 10 MG/5 ML SOLN	$0.26165	per ML	23 Sep 2026
US NADAC	NORTRIPTYLINE HCL 10 MG CAP	$0.11272	per EA	23 Sep 2026
US NADAC	NORTRIPTYLINE HCL 25 MG CAP	$0.15607	per EA	23 Sep 2026
US NADAC	NORTRIPTYLINE HCL 50 MG CAP	$0.20739	per EA	23 Sep 2026
US NADAC	NORTRIPTYLINE HCL 75 MG CAP	$0.27241	per EA	23 Sep 2026
NHS Drug Tariff	Nortriptyline 10mg capsules	£14.44	100 capsule	1 Oct 2026
NHS Drug Tariff	Nortriptyline 10mg tablets	£2.64	100 tablet	1 Oct 2026
NHS Drug Tariff	Nortriptyline 25mg capsules	£17.50	100 capsule	1 Oct 2026
NHS Drug Tariff	Nortriptyline 25mg tablets	£2.29	100 tablet	1 Oct 2026
NHS Drug Tariff	Nortriptyline 50mg tablets	£55.78	30 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 9 Apr 2019 PAMELOR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for nortriptyline →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.