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Medicine

Nabi-HB 1560 IU/5 mL injection

Human hepatitis b virus immune globulin · Intramuscular · ADMA Biologics
Available on requestPrescription onlyUS FDA Cold chain

Nabi-HB 1560 IU/5 mL injection is a prescription medicine containing Human hepatitis b virus immune globulin for intramuscular use, marketed by ADMA Biologics, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Refrigerate between 2 to 8 °C (36 to 46 °F). Do not freeze.

Key facts

Active ingredient (INN)
Human hepatitis b virus immune globulin
Brand
Nabi-HB
Strength
1560 IU/5 mL
Dosage form
Injection
Route
Intramuscular
Packs
1 vial
Marketing authorisation holder
ADMA Biologics
Manufacturer
ADMA Biologics
Origin register
US FDA, United States
Storage
Refrigerate between 2 to 8 °C (36 to 46 °F). Do not freeze.
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J06BB04 Human hepatitis b immunoglobulin
HS code (indicative)
3002.12Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
23 October 2001
Identifiers
RxCUI 1658125, 1658127DailyMed set ID 47fe1a99-5078-4b89-84fa-9e8387baec5cNDC 69800-4203Application BLA103945

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

PackCodeLabelerMarketed since
1 vial, single-use in 1 carton / 5 mL in 1 vial, single-use69800-4203-1ADMA Biologics23 October 2001

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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 hepatitis b virus immune globulin

Clinical summary

Human hepatitis b virus immune globulin is a human immunoglobulin indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, among other approved uses. MedsAcross supplies Human hepatitis b virus immune globulin 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 hepatitis b virus immune globulin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Nabi-HB 1560 IU/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.