Medicine
Epogen 4000 IU/mL injection
Epogen 4000 IU/mL injection is a prescription medicine containing Epoetin for intravenous, subcutaneous use, marketed by Amgen, 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 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Store Epogen…
Key facts
- Active ingredient (INN)
- Epoetin
- Brand
- Epogen
- Strength
- 4000 IU/mL
- Dosage form
- Injection
- Route
- Intravenous, subcutaneous
- Packs
- 10 vials
- Marketing authorisation holder
- Amgen
- Manufacturer
- Amgen
- Origin register
- US FDA, United States
- Storage
- Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Store Epogen vials in the original carton until use to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- B03XA02 Darbepoetin alfa
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 August 1993
- Identifiers
- RxCUI 205912, 205917, 205921 +7DailyMed set ID 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5NDC 55513-148Application BLA103234
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
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
Alternatives
Other makers and brands of Epoetin 4000 IU/mL injection.
Other strengths and forms of Epoetin
Clinical summary
Epoetin is an erythropoiesis-stimulating agent indicated for treatment of anemia due to, among other approved uses. It is available as injection for intravenous and subcutaneous use. MedsAcross supplies Epoetin 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 EpoetinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- EPOGEN prescribing information (Amgen) · U.S. National Library of Medicine, DailyMed
Need Epogen 4000 IU/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.