Digoxin 125 mcg tablet is a generic prescription medicine for oral use, made by 17 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store in a dry place at 20º to 25ºC (68º to 77ºF) and protect from light.
Key facts
- Active ingredient (INN)
- Digoxin
- Brand
- Sold under the generic name
- Strength
- 125 mcg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 500 tablets and 29 more
- Manufacturers
- Aurobindo PharmaIndiaBryant Ranch PrepackAmneal Pharmaceuticals of New YorkA-S Medication SolutionsAmneal Pharmaceuticals NYANI PharmaceuticalsHikma PharmaceuticalsMarlex PharmaceuticalsOliva TherapeuticsVangard Labs
- Origin register
- US FDA, United States
- Storage
- Store in a dry place at 20º to 25ºC (68º to 77ºF) and protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01AA05 Digoxin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 October 2007
- Identifiers
- RxCUI 197604, 197606, 245273DailyMed set ID 5886e233-b2da-4acb-be05-9bf40fb8e7f4, 5500ee2a-077d-486c-b56d-36e0c5e5c31d, 41c16cff-b03e-405e-a617-d6f45d3ce2bd +16NDC 0615-8202, 60687-858, 0143-1240 +16Application ANDA077002, ANDA215307, ANDA214982 +3
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 59651-437-01 | Aurobindo PharmaIndia | 8 February 2022 |
| 1000 tablet in 1 bottle | 59651-437-99 | Aurobindo PharmaIndia | 8 February 2022 |
| 100 tablet in 1 bottle | 69238-1991-1 | Amneal Pharmaceuticals NY | 1 April 2019 |
| 1000 tablet in 1 bottle | 69238-1991-7 | Amneal Pharmaceuticals NY | 1 April 2019 |
| 100 tablet in 1 bottle | 0115-9811-01 | Amneal Pharmaceuticals of New York | 20 July 2009 |
| 500 tablet in 1 bottle | 0115-9811-02 | Amneal Pharmaceuticals of New York | 20 July 2009 |
| 1000 tablet in 1 bottle | 0115-9811-03 | Amneal Pharmaceuticals of New York | 20 July 2009 |
| 100 tablet in 1 bottle | 70954-201-10 | ANI Pharmaceuticals | 22 November 2021 |
| 1000 tablet in 1 bottle | 70954-201-20 | ANI Pharmaceuticals | 22 November 2021 |
| 100 tablet in 1 bottle, plastic | 0143-1240-01 | Hikma Pharmaceuticals | 30 October 2007 |
| 1000 tablet in 1 bottle, plastic | 0143-1240-10 | Hikma Pharmaceuticals | 30 October 2007 |
| 100 tablet in 1 bottle | 82685-201-01 | Oliva Therapeutics | 1 September 2022 |
| 1000 tablet in 1 bottle | 82685-201-10 | Oliva Therapeutics | 1 September 2022 |
| 100 tablet in 1 bottle | 50090-5642-1 | A-S Medication Solutions | 10 September 2021 |
| 100 tablet in 1 bottle | 50090-6708-1 | A-S Medication Solutions | 28 September 2023 |
| 1000 tablet in 1 bottle | 71335-2463-1 | Bryant Ranch Prepack | 4 September 2024 |
| 100 tablet in 1 bottle | 71335-2463-2 | Bryant Ranch Prepack | 4 September 2024 |
| 1000 tablet in 1 bottle | 72162-2268-0 | Bryant Ranch Prepack | 21 February 2024 |
| 100 tablet in 1 bottle | 72162-2268-1 | Bryant Ranch Prepack | 21 February 2024 |
| 1000 tablet in 1 bottle | 72162-2268-2 | Bryant Ranch Prepack | 21 February 2024 |
| 100 tablet in 1 bottle | 72162-2268-4 | Bryant Ranch Prepack | 21 February 2024 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 60687-858-01 | American Health Packaging | 6 February 2025 |
| 50 blister pack in 1 box / 1 tablet in 1 blister pack | 50268-238-15 | AvPAK | 11 July 2024 |
| 10 blister pack in 1 bag / 1 tablet in 1 blister pack | 55154-5882-0 | Cardinal Health | 10 June 2009 |
| 30 tablet in 1 blister pack | 67046-1317-3 | Coupler | 10 June 2026 |
| 100 blister pack in 1 carton / 1 tablet in 1 blister pack | 0904-5921-61 | Major Pharmaceuticals | 10 June 2009 |
| 100 tablet in 1 bottle | 10135-747-01 | Marlex Pharmaceuticals | 1 June 2022 |
| 1000 tablet in 1 bottle | 10135-747-10 | Marlex Pharmaceuticals | 1 June 2022 |
| 30 tablet in 1 bottle, plastic | 51655-403-52 | Northwind Health | 13 April 2023 |
| 30 tablet in 1 blister pack | 70518-3859-0 | Remedyrepack | 11 September 2023 |
| 15 tablet in 1 blister pack | 0615-8202-05 | Vangard Labs | 7 July 2026 |
| 30 tablet in 1 blister pack | 0615-8202-39 | Vangard Labs | 7 July 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 16 November 1954 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Digoxin
Clinical summary
Digoxin is a cardiac glycoside indicated for treatment of mild to moderate heart failure in adults, among other approved uses. It is available as tablets, injection and oral solution for intramuscular and intravenous use. MedsAcross supplies Digoxin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DigoxinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LANOXIN prescribing information (Covis Pharma) · U.S. National Library of Medicine, DailyMed
Need Digoxin 125 mcg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.