Nortriptyline Hydrochloride

Relieves symptoms of depression. Sold as Aventyl Hydrochloride, Aventyl, Pamelor. Every FDA application for this active ingredient: 4 branded and 11 generic.

As of Nov 15, 2026, FDA lists 15 applications for Nortriptyline Hydrochloride (sold as Aventyl Hydrochloride, Aventyl, Pamelor), first approved Nov 6, 1964, with 3 new uses approved and 0 published complete response letters.

First approved: Nov 6, 1964
Applications: 15
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $21.7M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Nortriptyline HCl	Part D	$21.7M	+8%	312,704
Pamelor	Part D	$44K	-96%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

NORTRIPTYLINE 10 MG/5 ML SOLN: $0.256 per MLGeneric · -5% in a year
NORTRIPTYLINE HCL 10 MG CAP: $0.100 per unitGeneric · -14% in a year
NORTRIPTYLINE HCL 25 MG CAP: $0.145 per unitGeneric · -15% in a year
NORTRIPTYLINE HCL 50 MG CAP: $0.201 per unitGeneric · -11% in a year
NORTRIPTYLINE HCL 75 MG CAP: $0.266 per unitGeneric · -17% in a year

Clinical Trials

8 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Nortriptyline Compared With Amitriptyline for Migraine Prevention at SQUHMigraine · Sultan Qaboos University	Phase 4	Not yet recruiting	Oct 2, 2026
Modality Choice Before and After Failure for the Treatment of Painful Diabetic NeuropathyPainful Diabetic Neuropathy (PDN), Diabetic Nephropathies · University of Michigan	Phase 4	Not yet recruiting	Aug 31, 2026
Comparing Migraine Preventive Therapies vs. Anti-CGRP Therapies for Tinnitus in Patients With Migraine (COMPACT-PM)Migraine Associated Vertigo, Tinnitus · Stanford University	Phase 4	Not yet recruiting	Jun 17, 2026
Nortriptyline and the Risk of Serious Adverse EventsChronic Kidney Disease · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	—	Active, not recruiting	Apr 14, 2026
The Treatment of Painful Diabetic Neuropathy With DietPainful Diabetic Neuropathy (PDN), Peripheral Neuropathy With Type 2 Diabetes · AdventHealth	Not applicable	Recruiting	Apr 3, 2026
Procedural Framing and Epidural Steroid Injection OutcomesLumbosacral Radiculopathy · Northwestern University	Not applicable	Recruiting	Mar 27, 2026
An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain ServicePostsurgical Pain Management, Postsurgical Pain, Chronic · University of California, San Francisco	Phase 3	Not yet recruiting	Dec 22, 2025
Treatment of Meniere's Disease With Migraine MedicationsMénière · University of California, Irvine	Phase 4	Recruiting	Oct 17, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 6, 1964	Aventyl HydrochlorideNDA 14684 · New molecular entity	Lilly	28	Discontinued
Nov 6, 1964	AventylNDA 14685 · New dosage form	Ranbaxy	20	Discontinued
Aug 1, 1977	PamelorNDA 18012 · New formulation or manufacturer	Specgx LLC	19	Discontinued
Aug 1, 1977	PamelorNDA 18013 · New formulation or manufacturer	Specgx LLC	47	Discontinued
Mar 30, 1992	Nortriptyline HydrochlorideANDA 73556	Dr Reddys Labs SA	20	Marketed
Dec 31, 1992	Nortriptyline HydrochlorideANDA 74054	Ani Pharms	14	Discontinued
Jul 26, 1993	Nortriptyline HydrochlorideANDA 74234	Rising	13	Discontinued
Mar 27, 1995	Nortriptyline HydrochlorideANDA 74132	Teva	19	Marketed
Apr 11, 1996	Nortriptyline HydrochlorideANDA 73667	Teva	0	Discontinued
Jun 30, 1997	Nortriptyline HydrochlorideANDA 74835	Aurobindo Pharma Ltd	0	Discontinued
May 8, 2000	Nortriptyline HydrochlorideANDA 75520	Taro	6	Marketed
Aug 23, 2000	Nortriptyline HydrochlorideANDA 75606	Pharm Assoc	5	Marketed
Jun 20, 2006	Nortriptyline HydrochlorideANDA 77965	Taro	2	Discontinued
Feb 24, 2021	Nortriptyline HydrochlorideANDA 213441	Zydus Lifesciences	0	Discontinued
Aug 15, 2023	Nortriptyline HydrochlorideANDA 217731	Rubicon Research	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA