Medicine
Herceptin Hylecta 10000 units/600 mg per 5 mL injection
Herceptin Hylecta 10000 units/600 mg per 5 mL injection is a prescription medicine containing Hyaluronidase (human recombinant) and Trastuzumab for subcutaneous use, marketed by Genentech, 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 HERCEPTIN HYLECTA vials in the refrigerator at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Hyaluronidase (human recombinant) and Trastuzumab
- Brand
- Herceptin Hylecta
- Strength
- 10000 units/600 mg per 5 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Genentech
- Manufacturer
- Genentech
- Origin register
- US FDA, United States
- Storage
- Store HERCEPTIN HYLECTA vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Once removed from the refrigerator, HERCEPTIN HYLECTA must be administered within 4 hours and should not be kept above 30°C (86°F). Do not 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
- 28 February 2019
- Identifiers
- RxCUI 2119714, 2119719DailyMed set ID ebf30894-41cf-480c-8bc3-56f592a13813NDC 50242-077Application BLA761106
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 / 5 mL in 1 vial, single-dose | 50242-077-01 | Genentech | 28 February 2019 |
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
Hyaluronidase (human recombinant) and Trastuzumab is a fixed-dose combination of an endoglycosidase and an HER2/neu receptor antagonist indicated in adults for the treatment of HER2-overexpressing breast cancer, among other approved uses. MedsAcross supplies Hyaluronidase (human recombinant) and Trastuzumab 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 Hyaluronidase (human recombinant) and TrastuzumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Herceptin Hylecta prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
Need Herceptin Hylecta 10000 units/600 mg per 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.