Medicine
Hizentra 10 g/50 mL injection
Hizentra 10 g/50 mL injection is a prescription medicine containing Human immunoglobulin g for subcutaneous use, marketed by CSL Behring, 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
Store the HIZENTRA prefilled syringe or vial in its original carton to protect…
Key facts
- Active ingredient (INN)
- Human immunoglobulin g
- Brand
- Hizentra
- Strength
- 10 g/50 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 50 mL, 1 syringe of 50 mL
- Marketing authorisation holder
- CSL Behring
- Manufacturer
- CSL Behring
- Origin register
- US FDA, United States
- Storage
- Store the HIZENTRA prefilled syringe or vial in its original carton to protect it from light. Do not shake the HIZENTRA prefilled syringe or vial.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J06BA02 Human immunoglobulin g
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 3 October 2011
- Identifiers
- RxCUI 1809061, 1809063, 1809066 +7DailyMed set ID 7b58f5ff-0316-49a3-b585-1f6003ddb953NDC 44206-455Application BLA125350
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 50 mL in 1 vial, single-dose | 44206-455-10 | CSL Behring | 3 October 2011 |
| 1 syringe in 1 carton / 50 mL in 1 syringe | 44206-455-25 | CSL Behring | 3 October 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 |
| 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
Other strengths and forms of Human immunoglobulin g
Clinical summary
Human immunoglobulin g is a human immunoglobulin G indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). MedsAcross supplies Human immunoglobulin g 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 Human immunoglobulin gFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BIVIGAM prescribing information (ADMA Biologics) · U.S. National Library of Medicine, DailyMed
Need Hizentra 10 g/50 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.