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Medicine

Constulose 10 g/15 mL oral solution

Lactulose · Oral · Actavis Pharma
Available on requestPrescription onlyUS FDA

Constulose 10 g/15 mL oral solution is a prescription medicine containing Lactulose for oral use, marketed by Actavis Pharma, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Do not freeze. Prolonged exposure to freezing temperatures may cause change to…

Key facts

Active ingredient (INN)
Lactulose
Brand
Constulose
Strength
10 g/15 mL
Dosage form
Oral solution
Route
Oral
Packs
237 mL, 946 mL
Marketing authorisation holder
Actavis Pharma
Manufacturer
Actavis Pharma
Origin register
US FDA, United States
Storage
Do not freeze. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Store between 36° to 86°F (2° to 30°C). Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. Viscosity will return to normal upon warming to room temperature.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
A06AD11 Lactulose
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
28 February 2011
Identifiers
RxCUI 391937, 544452DailyMed set ID 461ec39f-eeb4-4460-9b5c-62367d47162bNDC 45963-439Application ANDA090503

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
237 mL in 1 bottle45963-439-63Actavis Pharma28 February 2011
946 mL in 1 bottle45963-439-65Actavis Pharma28 February 2011

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 25 March 1976Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Lactulose 10 g/15 mL oral solution.

Compare all 4

Other strengths and forms of Lactulose

Clinical summary

Lactulose is an osmotic laxative indicated for the treatment of constipation. It is available as oral solution and powder for oral solution for rectal use. MedsAcross supplies Lactulose for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Lactulose

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Constulose 10 g/15 mL oral solution for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.