United States· US:62135-002_49798265-6d70-8bc1-e063-6394a90a59d4
Lactulose
A lactulose product containing lactulose, registered in United States by Chartwell 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 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 · 10
- ndc1162135-002-24
- ndc1162135-002-37
- ndc1162135-002-47
- ndc1162135-002-78
- ndc1162135-002-94
- ndc1162135002242 TRAY in 1 BOX (62135-002-24) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (62135-002-51)
- ndc116213500237237 mL in 1 PACKAGE (62135-002-37)
- ndc116213500247473 mL in 1 PACKAGE (62135-002-47)
- ndc1162135002783785 mL in 1 PACKAGE (62135-002-78)
- ndc116213500294946 mL in 1 PACKAGE (62135-002-94)
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.
- FinlandDuphalacMylan Healthcare 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/ed993304-b9a6-44d7-8292-5afd60c2ed15 GET /v1/drugs/ed993304-b9a6-44d7-8292-5afd60c2ed15?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": "10",
"substance": "LACTULOSE",
"productndc": "62135-002",
"dosage_form": "SOLUTION",
"dea_schedule": null,
"strength_unit": "g/15mL",
"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.