Medicine
Ontruzant kit
Ontruzant kit is a generic prescription medicine for intravenous use, 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 Ontruzant vials in the refrigerator at 2° to 8°C (36° to 46°F) until…
Key facts
- Active ingredient (INN)
- Ontruzant
- Brand
- Sold under the generic name
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit
- Manufacturer
- Organon
- Origin register
- US FDA, United States
- Storage
- Store Ontruzant vials in the refrigerator at 2° to 8°C (36° to 46°F) until time of reconstitution.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XC03 Ontruzant
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2021
- Identifiers
- RxCUI 2289227, 2289232, 2289234 +1DailyMed set ID ce2a2492-85e3-4b0a-872a-047f44e4203dNDC 78206-148Application BLA761100
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 kit in 1 carton * 1 injection, powder, lyophilized, for solution in 1 vial, multi-dose * 1 injection, solution in 1 vial | 78206-148-01 | Organon | 1 June 2021 |
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
Ontruzant is an HER2/neu receptor antagonist indicated in adults for the treatment of HER2-overexpressing breast cancer, among other approved uses. It is available as kits for intravenous use. MedsAcross supplies Ontruzant 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 OntruzantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ontruzant prescribing information (Organon) · U.S. National Library of Medicine, DailyMed
Need Ontruzant kit 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.