Medicine
CroFab 1 g/1 g/1 g/1 g powder for injection
CroFab 1 g/1 g/1 g/1 g powder for injection is a prescription medicine containing Agkistrodon piscivorus immune fab antivenin (ovine), Crotalus adamanteus immune fab antivenin (ovine), Crotalus atrox immune fab antivenin (ovine) and Crotalus scutulatus immune fab antivenin (ovine) 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 vials at 2° to 8°C (36° to 46°F). Do not freeze. A temperature excursion…
Key facts
- Active ingredient (INN)
- Agkistrodon piscivorus immune fab antivenin (ovine), Crotalus adamanteus immune fab antivenin (ovine), Crotalus atrox immune fab antivenin (ovine) and Crotalus scutulatus immune fab antivenin (ovine)
- Brand
- CroFab
- Strength
- 1 g/1 g/1 g/1 g
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 2 vials
- Marketing authorisation holder
- BTG International
- Manufacturer
- BTG International
- Origin register
- US FDA, United States
- Storage
- Store vials at 2° to 8°C (36° to 46°F). Do not freeze. A temperature excursion for no longer than 7 days within the range of -20° to 25°C (-4° to 77°F) is permitted.
- 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
- 2 October 2000
- Identifiers
- RxCUI 885192, 885195DailyMed set ID 77abd784-3387-420d-abdc-4fe97215d233NDC 50633-110Application BLA103788
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 |
|---|---|---|---|
| 2 vial, glass in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, glass | 50633-110-12 | BTG International | 2 October 2000 |
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
Agkistrodon piscivorus immune fab antivenin (ovine), Crotalus adamanteus immune fab antivenin (ovine), Crotalus atrox immune fab antivenin (ovine) and Crotalus scutulatus immune fab antivenin (ovine) is a fixed-dose combination medicine. MedsAcross supplies Agkistrodon piscivorus immune fab antivenin (ovine), Crotalus adamanteus immune fab antivenin (ovine), Crotalus atrox immune fab antivenin (ovine) and Crotalus scutulatus immune fab antivenin (ovine) 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 Agkistrodon piscivorus immune fab antivenin (ovine), Crotalus adamanteus immune fab antivenin (ovine), Crotalus atrox immune fab antivenin (ovine) and Crotalus scutulatus immune fab antivenin (ovine)For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CroFab prescribing information (BTG International) · U.S. National Library of Medicine, DailyMed
Need CroFab 1 g/1 g/1 g/1 g 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.