Active substance
Digoxin
- SFDA 12
- US FDA 22
- Health Canada 8
- US price lines 4
- NHS prices 4
- WHO EML 2
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LANOXIN 0.05MG-ML ELIXIR | 0.05 µ/ml | Solution · Oral use | 1 Bottle | SAR 22.75 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| LANOXIN 0.125MG TAB | 0.125 mg | Tablet · Oral use | 100 Blister | SAR 16.10 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| LANOXIN 0.25MG TAB | 0.25 mg | Tablet · Oral use | 100 Blister | SAR 11.70 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| LANOXIN 0.25MG/ML INJ | 0.25 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 13.20 | Generic · Prescription | ASPEN | Valid |
| LANIBOS 0.25MG-2ML INJ. | 0.125 mg/ml | Solution · Intravenous use | 10 Ampoule | SAR 14.75 | NCE · Prescription | BOSNALIJEK PHARMACEUTICAL | Withdrawn by MAH · Not Marketed |
| LANOXIN 0.05MG-ML ELIXIR | 0.05 µ/ml | Solution · Oral use | 1 Bottle | SAR 22.75 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| LANOXIN 0.125MG TAB | 0.125 mg | Tablet · Oral use | 100 Tablet Container | SAR 16.10 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| LANOXIN 0.25MG TAB | 0.25 mg | Tablet · Oral use | 100 Tablet Container | SAR 11.70 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| LANOXIN 0.25MG-ML INJ | 0.25 mg/ml | Solution for injection · Intravenous use | 5 Ampoule | SAR 13.35 | Generic · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by regulatory authority · Not Marketed |
| LANOXIN 0.25MG/ML INJ | 0.25 mg/ml | Solution · Intravenous use | 5 Ampoule | SAR 13.20 | Generic · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| LANOXIN PG 0.0625MG TABLET | 0.0625 mg | Tablet · Oral use | 100 Tablet Container | SAR 6.40 | Generic · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| LANOXIN PG 0.0625MG TABLET | 0.0625 mg | Tablet · Oral use | 100 Tablet Container | SAR 6.45 | NCE · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by regulatory authority · Not Marketed |
Indications — CHI Daman Drug Formulary
ARRHYTHMIA; ATRIAL FIBRILLATION; CONGESTIVE HEART FAILURE; PULMONARY ARTERIAL HYPERTENSION; SUPRAVENTRICULAR TACHYCARDIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LANOXIN | 0.25MG/ML | injectable · injection | AZURITY | Prescription | 16 Nov 1954 |
| LANOXIN PEDIATRIC | 0.1MG/ML | injectable · injection | AZURITY | Prescription | 16 Nov 1954 |
| DIGOXIN | 0.25MG/ML | injectable · injection | HIKMA PHARMS | Prescription | 24 Oct 1975 |
| LANOXIN | 0.0625MG; 0.125MG; 0.25MG | tablet · oral | ADVANZ PHARMA | Prescription | 30 Sep 1997 |
| DIGOXIN | 0.125MG; 0.25MG | tablet · oral | RISING | Prescription | 23 Dec 1999 |
| DIGOXIN | 0.125MG; 0.25MG | tablet · oral | STEVENS J | Prescription | 26 Jul 2002 |
| DIGOXIN | 0.25MG/ML | injectable · injection | SANDOZ | Prescription | 21 Aug 2003 |
| DIGOXIN | 0.05MG/ML | elixir · oral | HIKMA PHARMS | Prescription | 26 Aug 2004 |
| DIGOXIN | 0.25MG; 0.125MG | tablet · oral | HIKMA INTL PHARMS | Prescription | 30 Oct 2007 |
| DIGOXIN | 0.05MG/ML | elixir · oral | VISTAPHARM LLC | Prescription | 4 Oct 2019 |
| DIGOXIN | 0.125MG; 0.25MG; 0.0625MG | tablet · oral | NOVITIUM PHARMA | Prescription | 22 Nov 2021 |
| DIGOXIN | 0.0625MG; 0.125MG; 0.25MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 8 Feb 2022 |
| DIGOXIN | 0.05MG/ML | elixir · oral | AMICI PHARMA | Prescription | 11 Mar 2022 |
| DIGOXIN | 0.25MG/ML | injectable · injection | WYETH AYERST | Discontinued | 12 Jul 1976 |
| LANOXICAPS | 0.2MG; 0.05MG; 0.1MG; 0.15MG | capsule · oral | GLAXOSMITHKLINE LLC | Discontinued | 26 Jul 1982 |
| DIGOXIN PEDIATRIC | 0.1MG/ML | injectable · injection | HOSPIRA | Discontinued | 25 Apr 1996 |
| DIGOXIN | 0.25MG/ML | injectable · injection | HOSPIRA | Discontinued | 16 May 1996 |
| LANOXIN | 0.1875MG; 0.375MG; 0.5MG | tablet · oral | ADVANZ PHARMA | Discontinued | 30 Sep 1997 |
| DIGOXIN | 0.25MG/ML | injectable · injection | HOSPIRA | Discontinued | 28 Aug 1998 |
| DIGOXIN | 0.125MG; 0.25MG | tablet · oral | SUN PHARM INDS INC | Discontinued | 31 Jan 2003 |
| DIGOXIN | 0.125MG; 0.25MG | tablet · oral | IMPAX LABS | Discontinued | 20 Jul 2009 |
| DIGOXIN | 0.25MG/ML | injectable · injection | ABRAXIS PHARM | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-DIGOXIN | 02554399 | 0.0625 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-DIGOXIN | 02554402 | 0.125 MG | TABLET · ORAL | AURO PHARMA INC |
| DIGOXIN INJECTION C.S.D. | 02048264 | 0.5 MG / 2 ML | LIQUID · INTRAMUSCULAR; INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| JAMP DIGOXIN | 02498502 | 0.0625 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP DIGOXIN | 02498510 | 0.125 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| PMS-DIGOXIN | 02242320 | 0.05 MG / ML | SOLUTION · ORAL | PHARMASCIENCE INC |
| PMS-DIGOXIN | 02335700 | 0.0625 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-DIGOXIN | 02335719 | 0.125 MG | TABLET · ORAL | PHARMASCIENCE INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DIGOXIN 0.05 MG/ML SOLUTION | $1.14686 | per ML | 23 Sep 2026 |
| US NADAC | DIGOXIN 125 MCG TABLET | $0.1327 | per EA | 23 Sep 2026 |
| US NADAC | DIGOXIN 250 MCG TABLET | $0.14843 | per EA | 23 Sep 2026 |
| US NADAC | DIGOXIN 62.5 MCG TABLET | $8.59432 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Digoxin 125microgram tablets | £1.69 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Digoxin 250microgram tablets | £1.58 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Digoxin 50micrograms/ml oral solution | £6.95 | 60 ml | 1 Oct 2026 |
| NHS Drug Tariff | Digoxin 62.5microgram tablets | £1.84 | 28 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 12.2. Antiarrhythmic medicines · core
Cardiac arrhythmia
Parenteral > General injections > IV: 250 µg per mL in 2 mL ampoule | Oral > Liquid: 50 µg per mL | Oral > Solid: 62.5 µg; 250 µg - 12.4. Medicines used in heart failure · core (EML); complementary (EMLc)
Heart failure
Parenteral > General injections > IV: 250 µg per mL in 2 mL ampoule; 100 µg per mL in 1 mL ampoule (EMLc) | Oral > Liquid: 50 µg per mL | Oral > Solid > tablet: 62.5 µg; 250 µg; 125 µg (EMLc)
Safety signals and safety-related labeling changes
- EMA PRAC 5 Jun 2025 PRAC signal: Laboratory test interference leading to falsely elevated digoxin plasma levels with enzalutamide
Action for MAH: update of the product information: Yes - US FDA 14 Apr 2025 DIGOXIN — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations - EMA PRAC 16 Jan 2025 PRAC signal: Laboratory test interference leading to falsely elevated digoxin plasma levels with enzalutamide
Action for MAH: update of the product information: No - US FDA 22 Feb 2019 LANOXIN — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations - US FDA 20 Sep 2018 LANOXIN — safety-related labeling change
Labeling sections changed: Drug Interactions; Use in Specific Populations - US FDA 24 Aug 2018 LANOXIN PEDIATRIC — safety-related labeling change
Labeling sections changed: Drug Interactions - EMA PRAC 10 Sep 2015 PRAC signal: Mortality in patients with atrial fibrillation
Action for MAH: update of the product information: No - EMA PRAC 7 May 2015 PRAC signal: Mortality in patients with atrial fibrillation
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.