Medicine
Venofer 50 mg/2.5 mL injection
Venofer 50 mg/2.5 mL injection is a prescription medicine containing Iron sucrose for intravenous use, marketed by American Regent, 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
Do not freeze. Store in original carton at 20°C to 25°C (68° F to 77° F)…
Key facts
- Active ingredient (INN)
- Iron sucrose
- Brand
- Venofer
- Strength
- 50 mg/2.5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 2.5 mL, 25 vials of 2.5 mL
- Marketing authorisation holder
- American Regent
- Manufacturers
- American RegentFresenius Medical Care Holdings
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store in original carton at 20°C to 25°C (68° F to 77° F), excursions permitted to 15° to 30°C (59° to 86°F). Intravenous Admixture Stability: Venofer, when added to intravenous infusion bags (PVC or non-PVC) containing 0.9% NaCl at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room…
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B03AB02 Iron sucrose
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 January 2011
- Identifiers
- RxCUI 1741267, 1741268, 1741270 +3DailyMed set ID f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040, 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619aNDC 49230-530, 0517-2325Application NDA021135
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 box / 2.5 mL in 1 vial, single-dose | 0517-2325-10 | American Regent | 27 January 2011 |
| 10 vial, single-dose in 1 box / 2.5 mL in 1 vial, single-dose | 49230-530-10 | Fresenius Medical Care Holdings | 27 January 2011 |
| 25 vial, single-dose in 1 tray / 2.5 mL in 1 vial, single-dose | 49230-530-25 | Fresenius Medical Care Holdings | 27 January 2011 |
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 6 November 2000 | 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
Alternatives
Other makers and brands of Iron sucrose 50 mg/2.5 mL injection.
Other strengths and forms of Iron sucrose
Clinical summary
Iron sucrose is a parenteral iron replacement indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). It is available as injection for intravenous and intravitreal use. MedsAcross supplies Iron sucrose 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 Iron sucroseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Venofer prescribing information (American Regent) · U.S. National Library of Medicine, DailyMed
Need Venofer 50 mg/2.5 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.