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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 040481

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NDA 040481 describes DIGOXIN, which is a drug marketed by Amici Pharma, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from twenty-eight suppliers. Additional details are available on the DIGOXIN profile page.

The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for 040481

Tradename:	DIGOXIN
Applicant:	Sandoz
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 040481

Medical Subject Heading (MeSH) Categories for 040481

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 040481

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	INJECTABLE;INJECTION	040481	ANDA	Sandoz Inc	0781-3059	0781-3059-95	10 AMPULE in 1 CARTON (0781-3059-95) / 2 mL in 1 AMPULE (0781-3059-72)
DIGOXIN	digoxin	INJECTABLE;INJECTION	040481	ANDA	Medical Purchasing Solutions, LLC	71872-7325	71872-7325-1	1 AMPULE in 1 BAG (71872-7325-1) / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.25MG/ML
Approval Date:	Aug 21, 2003	TE:	AP	RLD:	No

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