Medicine
Lactulose 10 g/15 mL oral solution
Lactulose 10 g/15 mL oral solution is a generic prescription medicine for oral, rectal use, made by 5 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, rectal
- Packs
- 237 mL, 473 mL, 946 mL and 16 more
- Manufacturers
- Bajaj MedicalRising Pharma HoldingsApozeal PharmaceuticalsKesin PharmaFresenius Kabi Austria
- 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
- 10 December 2012
- Identifiers
- RxCUI 391937DailyMed set ID a89835c9-8ce5-4627-8d7d-70ff175b2e07, a8af7389-3699-4873-b05a-509af7e8eaab, 2d90e2a4-334f-ab68-e063-6294a90affa6 +3NDC 18124-002, 83745-249, 81033-241 +2Application ANDA090502, ANDA203762, ANDA076645
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 |
|---|---|---|---|
| 237 mL in 1 bottle | 83745-249-08 | Apozeal Pharmaceuticals | 20 December 2024 |
| 473 mL in 1 bottle | 83745-249-16 | Apozeal Pharmaceuticals | 20 December 2024 |
| 946 mL in 1 bottle | 83745-249-32 | Apozeal Pharmaceuticals | 20 December 2024 |
| 236 mL in 1 bottle | 61037-471-02 | Bajaj Medical | 14 October 2021 |
| 946 mL in 1 bottle | 61037-471-03 | Bajaj Medical | 14 October 2021 |
| 1893 mL in 1 jug | 61037-471-04 | Bajaj Medical | 14 October 2021 |
| 15 mL in 1 cup, unit-dose | 61037-471-05 | Bajaj Medical | 14 October 2021 |
| 3785 mL in 1 jug | 61037-471-06 | Bajaj Medical | 14 October 2021 |
| 473 mL in 1 bottle | 61037-471-12 | Bajaj Medical | 14 October 2021 |
| 118 mL in 1 bottle | 61037-471-13 | Bajaj Medical | 14 October 2021 |
| 30 mL in 1 cup, unit-dose | 61037-471-14 | Bajaj Medical | 14 October 2021 |
| 473 mL in 1 bottle | 18124-002-16 | Fresenius Kabi Austria | 10 December 2012 |
| 118 mL in 1 bottle | 64980-592-12 | Rising Pharma Holdings | 25 May 2023 |
| 236 mL in 1 bottle | 64980-592-24 | Rising Pharma Holdings | 25 May 2023 |
| 473 mL in 1 bottle | 64980-592-48 | Rising Pharma Holdings | 25 May 2023 |
| 946 mL in 1 bottle | 64980-592-95 | Rising Pharma Holdings | 25 May 2023 |
| 946 mL in 1 bottle, plastic | 81033-241-32 | Kesin Pharma | 2 February 2025 |
| 100 cup, unit-dose in 1 case / 15 mL in 1 cup, unit-dose | 81033-241-50 | Kesin Pharma | 16 April 2024 |
| 100 cup, unit-dose in 1 case / 30 mL in 1 cup, unit-dose | 81033-241-51 | Kesin Pharma | 16 April 2024 |
| 1 bottle in 1 carton / 473 mL in 1 bottle | 51672-4243-9 | — | 2 June 2025 |
| 15 mL in 1 cup, unit-dose | 0121-0873-15 | — | 3 December 2019 |
| 473 mL in 1 bottle | 0121-0873-16 | — | 3 December 2019 |
| 946 mL in 1 bottle | 0121-0873-32 | — | 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 | — | 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 | — | 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 | — | 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 | — | 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 | — | 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 | — | 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 | — | 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 | — | 19 March 2024 |
| 237 mL in 1 package | 62135-002-37 | — | 19 March 2024 |
| 473 mL in 1 package | 62135-002-47 | — | 19 March 2024 |
| 3785 mL in 1 package | 62135-002-78 | — | 19 March 2024 |
| 946 mL in 1 package | 62135-002-94 | — | 19 March 2024 |
| 237 mL in 1 bottle, plastic | 62135-003-37 | — | 10 January 2021 |
| 473 mL in 1 bottle, plastic | 62135-003-47 | — | 10 January 2021 |
| 3785 mL in 1 bottle, plastic | 62135-003-78 | — | 10 January 2021 |
| 946 mL in 1 bottle, plastic | 62135-003-94 | — | 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 | — | 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 | — | 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 | — | 29 October 2025 |
| 473 mL in 1 bottle | 83745-405-16 | — | 20 December 2024 |
| 946 mL in 1 bottle | 83745-405-32 | — | 20 December 2024 |
| 237 mL in 1 bottle | 0527-5125-68 | — | 26 July 2001 |
| 473 mL in 1 bottle | 0527-5125-70 | — | 26 July 2001 |
| 946 mL in 1 bottle | 0527-5125-78 | — | 26 July 2001 |
| 1892 mL in 1 bottle | 0527-5125-82 | — | 26 July 2001 |
| 237 mL in 1 bottle | 0116-4005-08 | — | 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 | — | 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 | — | 1 July 2022 |
| 15 mL in 1 cup, unit-dose | 0116-4005-15 | — | 1 July 2022 |
| 473 mL in 1 bottle | 0116-4005-16 | — | 1 July 2022 |
| 30 mL in 1 cup, unit-dose | 0116-4005-30 | — | 1 July 2022 |
| 946 mL in 1 bottle | 0116-4005-32 | — | 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 | — | 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 | — | 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 | — | 14 September 2026 |
| 50 cup, unit-dose in 1 case / 30 mL in 1 cup, unit-dose | 17856-0874-3 | — | 26 September 2025 |
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 FDA40 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.