United States· US:68999-004_437b8b21-3264-1b6c-e063-6294a90a1d51
Lactulose
A lactulose product containing lactulose, registered in United States by Chartwell Governmental & Specialty RX, LLC.. The same ATC class is registered in 16 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Lactulose is registered in 16 of 19 countries.
Countries holding a registration under ATC A06AD11 (lactulose), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 8 of them publish a price we can compare per daily dose
Lactulose · ATC A06AD11
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LACTULOSE
- Manufacturer
- Chartwell Governmental & Specialty RX, LLC.
- Country
- United States (US)
- ATC code
- A06AD11
- ATC class
- Lactulose
- Defined daily dose
- 12.5 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168999004242 TRAY in 1 BOX (68999-004-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (68999-004-43)
- ndc1168999-004-24
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
657 interactions on record for lactulose.
Graded by severity as the source publishes them — 263 moderate. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Lactulose · interactions on record
657 records
- 263 moderate
- 18 minor
- 376 info
Most severe, free to view
- CisaprideA03FA02moderate
- OndansetronA04AA01moderate
- GranisetronA04AA02moderate
- DolasetronA04AA04moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Lactulose in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceLACTULOSE ARROW 10 g/15 ml, solution buvable en sachet-doseARROW GENERIQUES
- IrelandLactulose 10 g/15 ml Oral Solution SachetsFresenius Kabi Austria GmbH
- United KingdomBifiteral 10g oral powder sachetsImported (Germany)
- GermanyBifiteralCooper Consumer Health Deutschland Gmbh
- BelgiumBifiteral 66.7 g/100 mlCooper Consumer Health
- PolandDuphalacCooper Consumer Health B.V.
- FinlandDuphalacCooper Consumer Health B.V.
- SwitzerlandDuphalac
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Duphalac Fruit, Lactulose Genericon
- Belgium · Bifiteral, Duphalac
- Bulgaria · Дуфалак, Лактулакс
- Cyprus · Duphalac
- Czechia · Duphalac, Lactulosa Biomedica
- Germany · Bifiteral, Bifiteral Mit Pflaumenaroma
- Denmark · Lactulose Orifarm, Medilax
- Estonia · Duphalac, Duphalac Fruit
- Spain · Duphalac, Lactulosa Lainco
- Finland · Duphalac, Duphalac Fruit
- France · Duphalac, Lactulose Arrow
- United Kingdom (Northern Ireland) · Lactolax, Lactulose
- Greece · Duphafruit, Duphalac
- Croatia · Portalak, Portalak Efekt
- Ireland · Brillphalac, Lactecon
- Iceland · Medilax
- Italy · Duphalac, Epalfen Eps
- Lithuania · Duphalac, Duphalac Fruit
- Luxembourg · Bifiteral, Duphalac
- Latvia · Duphalac Fruit, Lactulose Mip
- Malta · Duphalac, Lactulose
- Netherlands · Duphalac, Duphalac Fruit
- Norway · Duphalac, Duphalac Med Fruktsmak
- Poland · Duphalac, Duphalac Fruit
- Portugal · Duphalac, Duphalac Ameixa
- Romania · Duphalac Fruit, Lactecon
- Sweden · Duphalac, Laktulos Cooper
- Slovenia · Prorektal
- Slovakia · Duphalac, Lactecon
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/ca3be499-c228-41a6-a396-f654e173e03e GET /v1/drugs/ca3be499-c228-41a6-a396-f654e173e03e?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": "20",
"substance": "LACTULOSE",
"productndc": "68999-004",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "g/30mL",
"application_number": "ANDA209517",
"marketing_category": "ANDA"
}See everything about lactulose.
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.