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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091681

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NDA 091681 describes DISULFIRAM, which is a drug marketed by Alvogen, Chartwell Molecules, Dash Pharms, Hikma, Sigmapharm Labs Llc, Strides Pharma Intl, Watson Labs, and Watson Labs Teva, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the DISULFIRAM profile page.

The generic ingredient in DISULFIRAM is disulfiram. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the disulfiram profile page.

Summary for 091681

Tradename:	DISULFIRAM
Applicant:	Alvogen
Ingredient:	disulfiram
Patents:	0

Pharmacology for NDA: 091681

Mechanism of Action	Acetyl Aldehyde Dehydrogenase Inhibitors

Medical Subject Heading (MeSH) Categories for 091681

Acetaldehyde Dehydrogenase Inhibitors
Alcohol Deterrents

Suppliers and Packaging for NDA: 091681

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DISULFIRAM	disulfiram	TABLET;ORAL	091681	ANDA	Alvogen Inc.	47781-607	47781-607-30	30 TABLET in 1 BOTTLE, PLASTIC (47781-607-30)
DISULFIRAM	disulfiram	TABLET;ORAL	091681	ANDA	Golden State Medical Supply, Inc.	60429-196	60429-196-01	100 TABLET in 1 BOTTLE (60429-196-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Aug 8, 2013	TE:	AB	RLD:	No

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