Medicine
Digoxin 0.05 mg/mL oral solution
Digoxin 0.05 mg/mL oral solution is a generic prescription medicine for oral use, made by 4 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 at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Digoxin
- Brand
- Sold under the generic name
- Strength
- 0.05 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 2.5 mL, 5 mL and 2 more
- Manufacturers
- Atlantic Biologicals CorpsAmici PharmaHikma PharmaceuticalsVistaPharm
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). 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
- 26 August 2004
- Identifiers
- RxCUI 393245DailyMed set ID ce62a741-a981-4880-8ce3-93269606a730, 1b7e5c6e-e052-41b0-a4ce-05dfe62faaaf, dcf907d9-0f0e-4ecc-a555-7e6dcc08c166 +1NDC 66689-327, 0054-0057, 17856-0057 +1Application ANDA213000, NDA021648, ANDA215209
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 60 mL in 1 bottle | 69292-605-60 | Amici Pharma | 10 June 2022 |
| 2.5 mL in 1 cup, unit-dose | 17856-0057-1 | Atlantic Biologicals Corps | 5 December 2011 |
| 5 mL in 1 cup | 17856-0057-5 | Atlantic Biologicals Corps | 24 September 2018 |
| 60 mL in 1 bottle | 0054-0057-46 | Hikma Pharmaceuticals | 26 August 2004 |
| 1 bottle, glass in 1 carton / 60 mL in 1 bottle, glass | 66689-327-02 | VistaPharm | 4 October 2019 |
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 0.05 mg/mL oral solution 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.