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Active ingredient

Digoxin

59 finished FDA listings contain Digoxin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
DIGOXIN
Dosage forms
Injection, Injection, Solution, Solution, Tablet
Routes
Intramuscular, Intravenous, Oral, Parenteral
Manufacturers / labelers
30
Strengths listed
.05 mg/ml · .0625 mg/1 · .125 mg/1 · .25 mg/1 · .25 mg/ml · 100 ug/ml · 125 ug/1 · 250 ug/1 · 250 ug/ml
Brand names in FDA listings
Lanoxin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3407

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 009330AZURITY1954-11-164
ANDA 083391HIKMA1975-10-246
NDA 020405ADVANZ PHARMA1997-09-304
ANDA 076268STEVENS J2002-07-2610
ANDA 076363SUN PHARM INDS INC2003-01-313
ANDA 040481SANDOZ2003-08-212
NDA 021648HIKMA2004-08-262
ANDA 077002HIKMA INTL PHARMS2007-10-307
ANDA 078556IMPAX LABS2009-07-202
ANDA 213000VISTAPHARM LLC2019-10-041
ANDA 215307NOVITIUM PHARMA2021-11-228
ANDA 214982AUROBINDO PHARMA LTD2022-02-089
ANDA 215209AMICI PHARMA2022-03-111

Official labeling on DailyMed

Showing the 12 most recent of 43 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.