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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213479

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NDA 213479 describes LEVORPHANOL TARTRATE, which is a drug marketed by Acertis Pharms, Hikma, Novitium Pharma, Specgx Llc, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the LEVORPHANOL TARTRATE profile page.

The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.

Summary for 213479

Tradename:	LEVORPHANOL TARTRATE
Applicant:	Novitium Pharma
Ingredient:	levorphanol tartrate
Patents:	0

Pharmacology for NDA: 213479

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 213479

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 213479

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213479	ANDA	Lannett Company, Inc.	0527-3236	0527-3236-37	100 TABLET in 1 BOTTLE (0527-3236-37)
LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213479	ANDA	Lannett Company, Inc.	0527-3237	0527-3237-37	100 TABLET in 1 BOTTLE (0527-3237-37)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jul 1, 2020	TE:	BX	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Jan 12, 2021	TE:	BX	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 20, 2021	TE:	BX	RLD:	No

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