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United States· US:17856-0310_4c2078a3-fd70-cb56-e063-6394a90a0ff9

GAVILAX

A medicinal product containing polyethylene glycol 3350, registered in United States by Atlantic Biologicals Corp..

Orange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedGAVILAXATC—REGISTER NO.US:17856-0310_4c2078a…PACKS LISTED1CHECKEDJune 3, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about polyethylene glycol 3350Answers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Polyethylene Glycol 3350
Manufacturer
Atlantic Biologicals Corp.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    1785603102
    72 POUCH in 1 CASE (17856-0310-2) / 2 g in 1 POUCH

Regulatory notes

UNII (FDA substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A091077
DailyMed SPL labels
1 version tracked

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.

All polyethylene glycol 3350 products

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/ab3a6ed0-dfc9-4378-859a-a1e4ebaf1d01
GET /v1/drugs/ab3a6ed0-dfc9-4378-859a-a1e4ebaf1d01?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.

{
  "unii": {
    "unii": "G2M7P15E5P",
    "rxcui": "221147",
    "inchikey": null,
    "display_name": "POLYETHYLENE GLYCOL 3350",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "21654def-5ae0-422d-961b-1fe2456af00a": {
      "match": "brand_token",
      "title": "GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2026-05-06"
    }
  },
  "productid": "17856-0310_4c2078a3-fd70-cb56-e063-6394a90a0ff9",
  "productndc": "17856-0310",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "091077",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Oct 6, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "002",
        "approval_date": "Jun 27, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350",
  "proprietary_name": "GAVILAX",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA091077",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350",
  "start_marketing_date": "20091009",
  "active_numerator_strength": "17"
}
API referenceMCP serverPlans

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.

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