Medicine
Darzalex 100 mg/5 mL injection
Darzalex 100 mg/5 mL injection is a prescription medicine containing Daratumumab for intravenous use, marketed by Janssen Biotech, 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 in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake…
Key facts
- Active ingredient (INN)
- Daratumumab
- Brand
- Darzalex
- Strength
- 100 mg/5 mL
- Dosage form
- Injection
- Route
- Intravenous
- Marketing authorisation holder
- Janssen Biotech
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FC01 Daratumumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 November 2015
- Identifiers
- RxCUI 1721951, 1721956, 1726439 +1DailyMed set ID a4d0efe9-5e54-467e-9eb4-56fa7d53b60bNDC 57894-502Application BLA761036
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
No pack sizes are recorded. Pack size and quantity are confirmed on the quote.
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.
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 Daratumumab 100 mg/5 mL injection.
Other strengths and forms of Daratumumab
Clinical summary
Daratumumab is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma. It is available as injection for intravenous use. MedsAcross supplies Daratumumab 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 DaratumumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DARZALEX prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Darzalex: European public assessment report (EPAR) · European Medicines Agency
Need Darzalex 100 mg/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.