Medicine
Gavilyte-n 420 g/1.48 g/5.72 g/11.2 g per 438.4 g powder for oral solution
Gavilyte-n 420 g/1.48 g/5.72 g/11.2 g per 438.4 g powder for oral solution is a prescription medicine containing Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chloride for oral use, marketed by Lupin, 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 25°C (77°F), excursions permitted to 15-30°C (59-86°F). When…
Key facts
- Active ingredient (INN)
- Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chloride
- Brand
- Gavilyte-n
- Strength
- 420 g/1.48 g/5.72 g/11.2 g per 438.4 g
- Dosage form
- Powder for oral solution
- Route
- Oral
- Marketing authorisation holder
- Lupin
- Manufacturer
- LupinIndia
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). When reconstituted, keep solution refrigerated.
- 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
- 28 May 2009
- Identifiers
- RxCUI 801054, 979099DailyMed set ID 27195187-75a3-431f-90d9-84da1b94e849NDC 43386-050Application ANDA090019
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
No pack sizes are recorded. Pack size and quantity are confirmed on the quote.
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 22 April 1991 | 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 Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chloride
Clinical summary
Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chloride is a fixed-dose combination of an osmotic laxative and a potassium salt. MedsAcross supplies Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chloride 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 Polyethylene glycol 3350, Potassium chloride, Sodium bicarbonate and Sodium chlorideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride prescribing information (Affordable Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Gavilyte-n 420 g/1.48 g/5.72 g/11.2 g per 438.4 g powder for oral solution 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.