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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075606

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NDA 075606 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rising, Taro, Teva, Zydus Lifesciences, Pharm Assoc, and Rubicon Research, and is included in eleven NDAs. It is available from twenty-six suppliers. Additional details are available on the NORTRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

Summary for 075606

Tradename:	NORTRIPTYLINE HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	nortriptyline hydrochloride
Patents:	0

Pharmacology for NDA: 075606

Medical Subject Heading (MeSH) Categories for 075606

Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic

Suppliers and Packaging for NDA: 075606

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	SOLUTION;ORAL	075606	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-0678	0121-0678-16	473 mL in 1 BOTTLE (0121-0678-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	EQ 10MG BASE/5ML
Approval Date:	Aug 23, 2000	TE:	AA	RLD:	No

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