Prescription medicine
Lactulose Brand names: Enulose, Kristalose, Generlac, Constulose; first approved as Cephulac
Lactulose (Enulose) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $8.22 per packet (Lactulose 10 g packet) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the lactulose FDA label on DailyMed (effective January 28, 2026, Chartwell RX, LLC); the NDA 17657 record on Drugs@FDA; every lactulose label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageFor the treatment of constipation.
Forms and strengths
- 10 g/15ml
- 10 g/10g
- 20 g/20g
- 20 g/30ml
Solution; powder for solution.
On the market
- Earliest approval on file
- March 25, 1976 Cephulac, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 29 first July 26, 1988; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 22 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $8.22 per packet Lactulose 10 g packet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2016 0 Class I among all firms' recalls; latest May 21, 2019; 2 more by firms not listed as its makers
- FAERS reports
- 38,214 through July 30, 2026
What is lactulose used for?
From the label: indications and usageFor the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
Conditions named in the indications of lactulose's FDA labels, with every medicine labeled for each:
From other lactulose labelsConstipation: INDICATION AND USAGE For the treatment of constipation.
FDA pharmacologic class: Osmotic Laxative.
Source: FDA drug label (Lactulose), Chartwell RX, LLC, effective January 28, 2026 (SPL set d6975cd8-80e0-43e2-809a-175ea7e40715), via openFDA; the full label on DailyMed
Is there a generic for lactulose (Enulose)?
The FDA approved the first generic lactulose on July 26, 1988. 29 generic applications are approved; 14 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lactulose from 22 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 1988 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lactulose (Enulose)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.22 per packet (Lactulose 10 g packet), up 10% from $7.51 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lactulose 10 g/15 mL solution (generic)
- Kristalose 10 g packet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Constulose 10 g/15 mL solution | Generic | $0.0194 per mL | n/a | +7% |
| Enulose 10 g/15 mL solution | Generic | $0.013 per mL | n/a | +0.9% |
| Generlac 10 g/15 mL solution | Generic | $0.013 per mL | n/a | +0.9% |
| Lactulose 10 g packet | Generic | $8.22 per packet | n/a | +10% |
| Lactulose 10 g/15 mL solution | Generic | $0.0194 per mL | n/a | +7% |
| Lactulose 20 g packet | Generic | $8.51 per packet | n/a | +6% |
| Lactulose 20 g/30 mL solution cup | Generic | $0.0512 per mL | n/a | +4% |
| Kristalose 10 g packet | Brand | $9.59 per packet | n/a | +2% |
| Kristalose 20 g packet | Brand | $9.96 per packet | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lactulose been recalled?
The FDA's Enforcement Report lists 9 recalls naming lactulose since 2016: 0 Class I (the most serious), 9 Class II, 0 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of lactulose and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| May 21, 2019 | Class II | Torrent Pharma Inc | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). |
| June 26, 2017 | Class II | VistaPharm, Inc. | Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. |
| January 18, 2017 | Class II | VistaPharm, Inc. | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. |
| November 9, 2016 | Class II | VistaPharm, Inc. | Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lactulose label say about other medicines?
The lactulose label names no other medicine on this site. The labels of 1 other medicine name lactulose. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name lactulose
Source: FDA drug label (Lactulose), Chartwell RX, LLC, effective January 28, 2026 (SPL set d6975cd8-80e0-43e2-809a-175ea7e40715), via openFDA; the full label on DailyMed
What do FAERS reports show for lactulose?
The FDA Adverse Event Reporting System holds 38,214 reports that list lactulose among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,670 are coded as a death and 20,957 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lactulose?
16 other medicines are given the same way (oral) and in the same FDA class as lactulose or labeled mainly for the same use (constipation), the same class first. Constipation lists all 20 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Polyethylene glycol 3350 | Constipation | 73 labelers | $0.0286 per gram 3350 powd | No current entry |
| Magnesium sulfate | Constipation | none listed | $0.0039 per gram Epsom salt | No current entry |
| Sodium phosphate dibasic and sodium phosphate monobasic | Constipation | 1 labeler | n/a | No current entry |
| Docusate | Constipation | none listed | $0.0276 per unit 100 mg softgel | No current entry |
| Sennosides | Constipation | none listed | $0.0258 per tablet 8.6 mg tablet | No current entry |
| Bisacodyl | Constipation | none listed | $0.0441 per tablet 5 mg tablet | No current entry |
| Magnesium hydroxide | Constipation | none listed | $0.0095 per mL Milk of magnesia suspension | No current entry |
| Magnesium citrate | Constipation | none listed | $0.0066 per mL Magnesium citrate solution | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lactulose compare with medicines for the same use?
7 side-by-side pages set lactulose beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lactulose
- 16 medicines for the same use
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Lactulose side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other