Medicine
Albutein 12.5 g/250 mL injection
Albutein 12.5 g/250 mL injection is a prescription medicine containing Albumin human for intravenous use, marketed by Grifols, 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
Protect from freezing. ALBUTEIN 5% is stable for three years provided the…
Key facts
- Active ingredient (INN)
- Albumin human
- Brand
- Albutein
- Strength
- 12.5 g/250 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 250 mL, 1 bag of 250 mL, 4 bags of 250 mL
- Marketing authorisation holder
- Grifols
- Manufacturer
- Grifols
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. ALBUTEIN 5% is stable for three years provided the storage temperature does not exceed 30 °C.
- Cold chain
- Not required on record
- 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
- 1 March 2022
- Identifiers
- RxCUI 1741405, 1741406DailyMed set ID 9c45986e-4e62-4f7d-971c-bec74dc4d234NDC 68516-5214, 68516-5218Application BLA102478
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 |
| US FDA | First approved 31 December 1997 | 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 Albumin human 12.5 g/250 mL injection.
- Albuked 12.5 g/250 mL injectionAvailable on requestKedrion BiopharmaUS FDA1 pack
- Albumin human 12.5 g/250 mL injectionAvailable on request—US FDA1 pack
- Albuminex 12.5 g/250 mL injectionAvailable on requestBplUS FDA1 pack
- Alburx 12.5 g/250 mL injectionAvailable on requestCSL BehringUS FDA1 pack
- Flexbumin 12.5 g/250 mL injectionAvailable on requestTakeda PharmaceuticalsUS FDA1 pack
- Plasbumin 12.5 g/250 mL injectionAvailable on requestGrifolsUS FDA1 pack
Other strengths and forms of Albumin human
Clinical summary
Albumin human is a human serum albumin indicated for hypovolemia and Hypoalbuminemia, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Albumin human 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 Albumin humanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- KEDBUMIN prescribing information (Kedrion Sp A) · U.S. National Library of Medicine, DailyMed
Need Albutein 12.5 g/250 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.