Medicine
Kristalose 10 g/10 g powder for oral solution
Kristalose 10 g/10 g powder for oral solution is a prescription medicine containing Lactulose for oral use, marketed by Cumberland Pharmaceuticals, 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
The packets are supplied as follows: NDC 66220-719-30 (Carton of thirty 10 g…
Key facts
- Active ingredient (INN)
- Lactulose
- Brand
- Kristalose
- Strength
- 10 g/10 g
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 30 pouches
- Marketing authorisation holder
- Cumberland Pharmaceuticals
- Manufacturer
- Cumberland Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- The packets are supplied as follows: NDC 66220-719-30 (Carton of thirty 10 g packets) NDC 66220-729-30 (Carton of thirty 20 g packets) STORE AT ROOM TEMPERATURE, 15°-30°C (59°-86°F).
- 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
- 20 January 2012
- Identifiers
- RxCUI 1251190, 1251192, 1251194 +1DailyMed set ID 535dd1ea-b567-49f7-9a84-8ea91e78c466NDC 66220-729, 66220-719Application ANDA074712
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 pouch in 1 carton / 10 g in 1 pouch | 66220-719-30 | Cumberland Pharmaceuticals | 20 January 2012 |
| 30 pouch in 1 carton / 20 g in 1 pouch | 66220-729-30 | Cumberland Pharmaceuticals | 20 January 2012 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 25 March 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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/10 g powder for oral solution.
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 LactuloseFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Lactulose prescribing information (Foxland Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Kristalose 10 g/10 g powder for 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.