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United States· US:0990-7981_fba5680c-d4e6-461a-95e3-25edd33ba39c

Sorbitol-Mannitol

A medicinal product containing sorbitol; mannitol, registered in United States by ICU Medical Inc..

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSorbitol-MannitolATC—REGISTER NO.US:0990-7981_fba5680c…PACKS LISTED1CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
SORBITOL; MANNITOL
Manufacturer
ICU Medical 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 · 1

  • ndc11
    0990-7981-08

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Sorbitol; mannitol in 2 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All sorbitol; mannitol products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • Portugal · Osmofundina Concentrada

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/d78fa6d3-06b8-4a9b-a6ad-16bf06f0623a
GET /v1/drugs/d78fa6d3-06b8-4a9b-a6ad-16bf06f0623a?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": "URETHRAL",
  "source": "ndc",
  "strength": "2.7; .54",
  "substance": "SORBITOL; MANNITOL",
  "productndc": "0990-7981",
  "dosage_form": "IRRIGANT",
  "dea_schedule": null,
  "strength_unit": "g/100mL; g/100mL",
  "application_number": "NDA018316",
  "marketing_category": "NDA"
}

See everything about sorbitol; mannitol.

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.