Medicine
Prezcobix Ped 90 mg/600 mg tablet for oral suspension
Prezcobix Ped 90 mg/600 mg tablet for oral suspension is a prescription medicine containing Cobicistat and Darunavir ethanolate for oral use, marketed by Janssen Products, 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 at 20 °C to 25 °C (between 68 °F to 77 °F), with excursions permitted to…
Key facts
- Active ingredient (INN)
- Cobicistat and Darunavir ethanolate
- Brand
- Prezcobix Ped
- Strength
- 90 mg/600 mg
- Dosage form
- Tablet for oral suspension
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Janssen Products
- Manufacturer
- Janssen Products
- Origin register
- US FDA, United States
- Storage
- Store at 20 °C to 25 °C (between 68 °F to 77 °F), with excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). Storage of PREZCOBIX PED tablets for oral suspension: Store in the original container in order to protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 February 2026
- Identifiers
- RxCUI 1600704, 1600710, 2710424 +3DailyMed set ID 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9fNDC 59676-577Application NDA220092
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 |
|---|---|---|---|
| 30 tablet, for suspension in 1 bottle | 59676-577-30 | Janssen Products | 27 February 2026 |
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 29 January 2015 | 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
Other strengths and forms of Cobicistat and Darunavir ethanolate
Clinical summary
Cobicistat and Darunavir ethanolate is a fixed-dose combination of a cytochrome P450 3A inhibitor and a protease inhibitor. It is available as tablets and tablet for oral suspension. MedsAcross supplies Cobicistat and Darunavir ethanolate 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 Cobicistat and Darunavir ethanolateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PREZCOBIX prescribing information (Janssen Products) · U.S. National Library of Medicine, DailyMed
Need Prezcobix Ped 90 mg/600 mg tablet for oral suspension 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.