Medicine
DigiFab 40 mg powder for injection
DigiFab 40 mg powder for injection is a prescription medicine containing Ovine digoxin immune fab for intravenous use, marketed by BTG International, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store at 2 ° to 8 ° C (36 ° to 46 ° F). Do not freeze.
Key facts
- Active ingredient (INN)
- Ovine digoxin immune fab
- Brand
- DigiFab
- Strength
- 40 mg
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- BTG International
- Manufacturers
- BTG InternationalSalvagenix
- Origin register
- US FDA, United States
- Storage
- Store at 2 ° to 8 ° C (36 ° to 46 ° F). Do not freeze.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 August 2001
- Identifiers
- RxCUI 349326, 404702DailyMed set ID 49ee0505-77a0-1ff4-e063-6294a90a410eNDC 87131-120, 50633-120Application BLA103910
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass | 50633-120-11 | BTG International | 31 August 2001 |
| 1 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass | 87131-120-11 | Salvagenix | 20 March 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 |
| 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
Clinical summary
Ovine digoxin immune fab is a cardiac glycoside indicated for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, including known suicidal or accidental consumption of fatal doses of digoxin. MedsAcross supplies Ovine digoxin immune fab 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 Ovine digoxin immune fabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DigiFab prescribing information (Salvagenix) · U.S. National Library of Medicine, DailyMed
Need DigiFab 40 mg powder for 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.