United States· US:43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592
GAVILAX
A medicinal product containing polyethylene glycol 3350, registered in United States by Lupin Pharmaceuticals,Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- POLYETHYLENE GLYCOL 3350
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc114338631208238 g in 1 BOTTLE (43386-312-08)
- ndc114338631214510 g in 1 BOTTLE (43386-312-14)
- ndc1143386-312-08
- ndc1143386-312-14
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Polyethylene glycol 3350 in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomCosmoCol Half oral powder 6.9g sachetsStirling Anglian Pharmaceuticals Ltd
- CanadaCLEARLAXPERRIGO INTERNATIONAL
- BelgiumColopegBayer
- FranceMACROGOL 3350 MAYOLY SPINDLER 8,5 g, poudre pour solution buvable en sachetLABORATOIRES MAYOLY SPINDLER
- FinlandTransipegBayer Oy
- GermanyMacrogol AdgcZentiva Pharma Gmbh
- IrelandTransisoft 8.5 g powder for oral solution in sachetLaboratoires Mayoly Spindler
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Belgium · Transisoft
- Germany · Transisoft
- France · Transipeg, Transipeglib
- United Kingdom (Northern Ireland) · Transisoft
- Ireland · Transisoft
- Italy · Transisoft
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/d1931e9d-a1e8-453b-8451-e63a04786d0d GET /v1/drugs/d1931e9d-a1e8-453b-8451-e63a04786d0d?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "17",
"substance": "POLYETHYLENE GLYCOL 3350",
"productndc": "43386-312",
"dosage_form": "POWDER, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "g/17g",
"application_number": "ANDA091077",
"marketing_category": "ANDA"
}See everything about polyethylene glycol 3350.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.