Medicine
Digoxin 0.5 mg/2 mL injection
Digoxin 0.5 mg/2 mL injection is a generic prescription medicine for intramuscular, intravenous use, made by 5 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), excursions permitted to 15˚ to 30˚C (59˚…
Key facts
- Active ingredient (INN)
- Digoxin
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/2 mL
- Dosage form
- Injection
- Route
- Intramuscular, intravenous
- Packs
- 25 ampules of 2 mL, 5 ampules of 2 mL, 2 mL and 3 more
- Manufacturers
- Hikma PharmaceuticalsCardinal HealthHealthFirstHenry ScheinProPharma Distribution
- Origin register
- US FDA, United States
- Storage
- Store at 20˚ to 25˚C (68˚ to 77˚F), excursions permitted to 15˚ to 30˚C (59˚ to 86˚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
- 24 October 1975
- Identifiers
- RxCUI 104208DailyMed set ID 6aba2b38-5de0-4813-9775-39d87613893d, 98d2ad5b-9ffa-4456-9a01-567636c3a4d2, 3933b07f-5857-4a80-b502-e3214bdf9330 +3NDC 55154-5106, 0404-9850, 0641-1410 +3Application ANDA083391
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 |
|---|---|---|---|
| 25 ampule in 1 carton / 2 mL in 1 ampule | 0641-1410-35 | Hikma Pharmaceuticals | 24 October 1975 |
| 25 ampule in 1 carton / 2 mL in 1 ampule | 0641-6184-25 | Hikma Pharmaceuticals | 24 October 1975 |
| 5 ampule in 1 bag / 2 mL in 1 ampule | 55154-5106-5 | Cardinal Health | 28 June 2011 |
| 2 mL in 1 ampule | 51662-1217-1 | HealthFirst | 13 September 2018 |
| 1 ampule in 1 bag / 2 mL in 1 ampule | 0404-9850-02 | Henry Schein | 10 January 2022 |
| 2 mL in 1 ampule | 84549-410-35 | ProPharma Distribution | 11 December 2025 |
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 0.5 mg/2 mL injection 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.