Medicine
Iron sucrose 50 mg/2.5 mL injection
Iron sucrose 50 mg/2.5 mL injection is a generic prescription medicine for intravenous use, made by 3 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
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
- Sold under the generic name
- Strength
- 50 mg/2.5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 10 vials of 2.5 mL, 25 vials of 2.5 mL and 1 more
- Manufacturers
- SandozInternational Medication SystemsMylan Institutional
- 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: Iron sucrose injection, 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…
- 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
- 8 August 2025
- Identifiers
- RxCUI 1741261, 1741267, 1741270DailyMed set ID 78c04f10-0489-4e45-8cb5-28a6789d1149, 3f109bdb-a412-43b2-84c7-9dad05e85a71, 6f19c80e-22e9-4bab-aa53-4d2d958119edNDC 0781-3485, 67457-957, 76329-9200Application ANDA212340, ANDA212559, ANDA208977
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 |
|---|---|---|---|
| 10 vial, single-dose in 1 package / 2.5 mL in 1 vial, single-dose | 76329-9200-1 | International Medication Systems | 12 August 2025 |
| 10 vial, single-dose in 1 carton / 2.5 mL in 1 vial, single-dose | 67457-957-99 | Mylan Institutional | 8 August 2025 |
| 10 vial, single-dose in 1 carton / 2.5 mL in 1 vial, single-dose | 0781-3485-95 | Sandoz | 22 September 2025 |
| 25 vial, single-dose in 1 carton / 2.5 mL in 1 vial, single-dose | 0781-3485-96 | Sandoz | 22 September 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 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 Iron sucrose 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.