Quick answers
- What is Digoxin used for?
- The FDA-approved label (Lanoxin, Covis Pharma US, Inc, October 17, 2025) says: “LANOXIN is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. Increasing myocardial contractility in pediatric patients with heart failure. Control of resting ventricular rate in adults with chronic atrial fibrillation. 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Digoxin have a boxed warning?
- No. None of the 43 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Digoxin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Digoxin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 25, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Digoxin?
- 30 companies list prescription products of Digoxin in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Bryant Ranch Prepack and A-S Medication Solutions.
What Digoxin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LANOXIN is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. Increasing myocardial contractility in pediatric patients with heart failure. Control of resting ventricular rate in adults with chronic atrial fibrillation. 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. …
— FDA label: Lanoxin, Covis Pharma US, Inc, effective October 17, 2025. Read the full label on DailyMed →
The FDA has 43 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 43 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Injection, solution · Injection · Solution |
|---|---|
| Route | Oral · Intramuscular · Intravenous · Parenteral |
| Prescription products | 59 in the FDA NDC Directory |
| Brand names | Lanoxin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| digoxin 0.05 mg/mL solution | Generic | $1.14 per mL |
| digoxin 0.0625 mg tablet | Generic | $8.63 per tablet |
| digoxin 0.125 mg tablet | Generic | $0.1233 per tablet |
| digoxin 0.25 mg tablet | Generic | $0.1445 per tablet |
| digoxin 125 ug tablet | Generic | $0.1233 per tablet |
| digoxin 250 ug tablet | Generic | $0.1445 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hikma Pharmaceuticals USA Inc.5 products
- Bryant Ranch Prepack5 products
- A-S Medication Solutions5 products
- Covis Pharma US, Inc4 products
- Advanz Pharma (US) Corp.3 products
- ANI Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Oliva Therapeutics, LLC2 products
- Remedyrepack Inc.2 products
- Major Pharmaceuticals2 products
- Marlex Pharmaceuticals, Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- Cardinal Health 107, LLC2 products
- American Health Packaging2 products
- Amneal Pharmaceuticals of New York LLC2 products
- Proficient Rx LP1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- Golden State Medical Supply, Inc.1 product
- Amici Pharma, Inc.1 product
- Atlantic Biologicals Corps1 product
- Henry Schein, Inc.1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Medical Purchasing Solutions, LLC1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
- ProPharma Distribution1 product
- AvPAK1 product
- VistaPharm, LLC1 product
- Sandoz Inc1 product
- Northwind Health Company, LLC1 product
- Coupler LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA009330 LANOXIN, LANOXIN PEDIATRIC | Azurity | November 16, 1954 | 17, latest October 9, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
| NDA020405 LANOXIN | Advanz Pharma | September 30, 1997 | 14, latest April 29, 2024 2024: Labeling · 2019: Labeling · 2018: Labeling |
| NDA021648 DIGOXIN | Hikma | August 26, 2004 | 9, latest April 14, 2025 2025: Labeling · 2024: Labeling · 2018: Labeling |
Generic approvals (10)
- ANDA083391Hikma · October 24, 1975
- ANDA076268Stevens J · July 26, 2002
- ANDA076363Sun Pharm Inds Inc · January 31, 2003
- ANDA040481Sandoz · August 21, 2003
- ANDA077002Hikma · October 30, 2007
- ANDA078556Impax Labs · July 20, 2009
- ANDA213000Vistapharm LLC · October 4, 2019
- ANDA215307Novitium Pharma · November 22, 2021
- ANDA214982Aurobindo Pharma Ltd · February 8, 2022
- ANDA215209Pangea · March 11, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 25, 2024 · Class III · Terminated · D-0443-2024
Failed Impurities/Degradation Specifications
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10 — Novitium Pharma LLC
-
March 4, 2024 · Class III · Terminated · D-0389-2024
Cross Contamination with Other Products:(mycophenolate mofetil).
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20 — Novitium Pharma LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lanoxin, Covis Pharma US, Inc, effective October 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →