Medicine
Darzalex Faspro 1800 mg/30000 units per 15 mL injection
Darzalex Faspro 1800 mg/30000 units per 15 mL injection is a prescription medicine containing Daratumumab and Hyaluronidase (human recombinant) for subcutaneous 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 DARZALEX FASPRO vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in…
Key facts
- Active ingredient (INN)
- Daratumumab and Hyaluronidase (human recombinant)
- Brand
- Darzalex Faspro
- Strength
- 1800 mg/30000 units per 15 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Janssen Biotech
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Store DARZALEX FASPRO vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 2020
- Identifiers
- RxCUI 2375136, 2375141DailyMed set ID 4bb241af-4299-4373-8762-2d6709515db0NDC 57894-503Application BLA761145
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 box / 15 mL in 1 vial, single-dose | 57894-503-01 | Janssen Biotech | 1 May 2020 |
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
Clinical summary
Daratumumab and Hyaluronidase (human recombinant) is a fixed-dose combination of a CD38-directed cytolytic antibody and an endoglycosidase indicated for the treatment of adult patients with multiple myeloma, among other approved uses. MedsAcross supplies Daratumumab and Hyaluronidase (human recombinant) 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 Daratumumab and Hyaluronidase (human recombinant)For 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 Faspro prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
Need Darzalex Faspro 1800 mg/30000 units per 15 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.