Medicine
Harvoni 90 mg/400 mg tablet
Harvoni 90 mg/400 mg tablet is a prescription medicine containing Ledipasvir and Sofosbuvir for oral use, marketed by Gilead Sciences, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store below 30 °C (86 °F).
Key facts
- Active ingredient (INN)
- Ledipasvir and Sofosbuvir
- Brand
- Harvoni
- Strength
- 90 mg/400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 28 tablets
- Marketing authorisation holder
- Gilead Sciences
- Manufacturer
- Gilead Sciences
- Origin register
- US FDA, United States
- Storage
- Store below 30 °C (86 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AP51 Ledipasvir and Sofosbuvir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 October 2014
- Identifiers
- DailyMed set ID f4ec77e4-bae8-4db0-b3d5-bde09c5fa075NDC 61958-1801Application NDA205834
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 |
|---|---|---|---|
| 28 tablet, film coated in 1 bottle, plastic | 61958-1801-1 | Gilead Sciences | 10 October 2014 |
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 |
| US FDA | First approved 10 October 2014 | Drugs@FDA |
| 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
Alternatives
Other makers and brands of Ledipasvir and Sofosbuvir 90 mg/400 mg tablet.
Other strengths and forms of Ledipasvir and Sofosbuvir
Clinical summary
Ledipasvir and Sofosbuvir is a fixed-dose combination of a hepatitis C virus NS5A inhibitor and a hepatitis C virus nucleotide analog NS5B polymerase inhibitor indicated for the treatment of adults, among other approved uses. MedsAcross supplies Ledipasvir and Sofosbuvir 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 Ledipasvir and SofosbuvirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Harvoni prescribing information (Gilead Sciences) · U.S. National Library of Medicine, DailyMed
Need Harvoni 90 mg/400 mg tablet 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.