Medicine
Lactulose 10 g/15 mL oral solution
Lactulose 10 g/15 mL oral solution is a generic prescription medicine for oral use, made by 11 labelers, 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
Do not freeze. Prolonged exposure to freezing temperatures may cause change to…
Key facts
- Active ingredient (INN)
- Lactulose
- Brand
- Sold under the generic name
- Strength
- 10 g/15 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 1 bottle, 15 mL, 473 mL and 40 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaChartwell RXPAI PharmaXttrium LaboratoriesLannettAmerican Health PackagingApozeal PharmaceuticalsChartwell Governmental & Specialty RXAtlantic Biologicals11 labelers on the register
- 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 15° to 30°C (59° to 86°F). Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be harmaceutically 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
- 30 July 1966
- Identifiers
- RxCUI 391937DailyMed set ID 6619b25c-26b7-4c43-8c4f-9d33a23c61ca, 72ac130a-de85-464d-9e9b-05cac0c54db1, 0f19e4ed-c90a-4330-a7fa-bf911aa98f09 +10NDC 0527-5125, 83745-405, 0121-1154 +14Application ANDA075993, ANDA207786, ANDA074623 +4
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 473 mL in 1 bottle | 51672-4243-9 | Sun Pharmaceutical IndustriesIndia | 2 June 2025 |
| 15 mL in 1 cup, unit-dose | 0121-0873-15 | PAI Pharma | 3 December 2019 |
| 473 mL in 1 bottle | 0121-0873-16 | PAI Pharma | 3 December 2019 |
| 946 mL in 1 bottle | 0121-0873-32 | PAI Pharma | 3 December 2019 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 0121-1154-00 | PAI Pharma | 3 May 2019 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 0121-1154-40 | PAI Pharma | 3 May 2019 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 0121-1746-00 | PAI Pharma | 3 December 2019 |
| 6 carton in 1 case / 16 cup, unit-dose in 1 carton / 30 mL in 1 cup, unit-dose | 0121-1746-06 | PAI Pharma | 3 December 2019 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 0121-1746-40 | PAI Pharma | 3 December 2019 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 0121-4577-40 | PAI Pharma | 30 July 1966 |
| 5 tray in 1 case / 5 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 0121-4577-50 | PAI Pharma | 19 November 2022 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 62135-002-24 | Chartwell RX | 19 March 2024 |
| 237 mL in 1 package | 62135-002-37 | Chartwell RX | 19 March 2024 |
| 473 mL in 1 package | 62135-002-47 | Chartwell RX | 19 March 2024 |
| 3785 mL in 1 package | 62135-002-78 | Chartwell RX | 19 March 2024 |
| 946 mL in 1 package | 62135-002-94 | Chartwell RX | 19 March 2024 |
| 237 mL in 1 bottle, plastic | 62135-003-37 | Chartwell RX | 10 January 2021 |
| 473 mL in 1 bottle, plastic | 62135-003-47 | Chartwell RX | 10 January 2021 |
| 3785 mL in 1 bottle, plastic | 62135-003-78 | Chartwell RX | 10 January 2021 |
| 946 mL in 1 bottle, plastic | 62135-003-94 | Chartwell RX | 10 January 2021 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 62135-004-24 | Chartwell RX | 19 March 2024 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 68999-002-24 | Chartwell Governmental & Specialty RX | 29 October 2025 |
| 2 tray in 1 box / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 68999-004-24 | Chartwell Governmental & Specialty RX | 29 October 2025 |
| 473 mL in 1 bottle | 83745-405-16 | Apozeal Pharmaceuticals | 20 December 2024 |
| 946 mL in 1 bottle | 83745-405-32 | Apozeal Pharmaceuticals | 20 December 2024 |
| 237 mL in 1 bottle | 0527-5125-68 | Lannett | 26 July 2001 |
| 473 mL in 1 bottle | 0527-5125-70 | Lannett | 26 July 2001 |
| 946 mL in 1 bottle | 0527-5125-78 | Lannett | 26 July 2001 |
| 1892 mL in 1 bottle | 0527-5125-82 | Lannett | 26 July 2001 |
| 237 mL in 1 bottle | 0116-4005-08 | Xttrium Laboratories | 1 July 2022 |
| 100 case in 1 case / 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 0116-4005-10 | Xttrium Laboratories | 1 July 2022 |
| 100 case in 1 case / 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 0116-4005-11 | Xttrium Laboratories | 1 July 2022 |
| 15 mL in 1 cup, unit-dose | 0116-4005-15 | Xttrium Laboratories | 1 July 2022 |
| 473 mL in 1 bottle | 0116-4005-16 | Xttrium Laboratories | 1 July 2022 |
| 30 mL in 1 cup, unit-dose | 0116-4005-30 | Xttrium Laboratories | 1 July 2022 |
| 946 mL in 1 bottle | 0116-4005-32 | Xttrium Laboratories | 1 July 2022 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 60687-917-14 | American Health Packaging | 8 October 2026 |
| 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 15 mL in 1 cup, unit-dose | 60687-917-64 | American Health Packaging | 19 October 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 30 mL in 1 cup, unit-dose | 60687-917-76 | American Health Packaging | 14 September 2026 |
| 50 cup, unit-dose in 1 case / 30 mL in 1 cup, unit-dose | 17856-0874-3 | Atlantic Biologicals | 26 September 2025 |
| 237 mL in 1 bottle | 83745-249-08 | — | 20 December 2024 |
| 473 mL in 1 bottle | 83745-249-16 | — | 20 December 2024 |
| 946 mL in 1 bottle | 83745-249-32 | — | 20 December 2024 |
| 236 mL in 1 bottle | 61037-471-02 | — | 14 October 2021 |
| 946 mL in 1 bottle | 61037-471-03 | — | 14 October 2021 |
| 1893 mL in 1 jug | 61037-471-04 | — | 14 October 2021 |
| 15 mL in 1 cup, unit-dose | 61037-471-05 | — | 14 October 2021 |
| 3785 mL in 1 jug | 61037-471-06 | — | 14 October 2021 |
| 473 mL in 1 bottle | 61037-471-12 | — | 14 October 2021 |
| 118 mL in 1 bottle | 61037-471-13 | — | 14 October 2021 |
| 30 mL in 1 cup, unit-dose | 61037-471-14 | — | 14 October 2021 |
| 473 mL in 1 bottle | 18124-002-16 | — | 10 December 2012 |
| 118 mL in 1 bottle | 64980-592-12 | — | 25 May 2023 |
| 236 mL in 1 bottle | 64980-592-24 | — | 25 May 2023 |
| 473 mL in 1 bottle | 64980-592-48 | — | 25 May 2023 |
| 946 mL in 1 bottle | 64980-592-95 | — | 25 May 2023 |
| 946 mL in 1 bottle, plastic | 81033-241-32 | — | 2 February 2025 |
| 100 cup, unit-dose in 1 case / 15 mL in 1 cup, unit-dose | 81033-241-50 | — | 16 April 2024 |
| 100 cup, unit-dose in 1 case / 30 mL in 1 cup, unit-dose | 81033-241-51 | — | 16 April 2024 |
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/15 mL oral solution.
- Lactulose 10 g/15 mL oral solutionAvailable on request—US FDA19 packs
- Enulose 10 g/15 mL oral solutionAvailable on requestActavis PharmaUS FDA2 packs
- Constulose 10 g/15 mL oral solutionAvailable on requestActavis PharmaUS FDA2 packs
- Generlac 10 g/15 mL oral solutionAvailable on requestChartwell RXUS FDA2 packs
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 Lactulose 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.