Quick answers
- What is Lactulose used for?
- The FDA-approved label (Kristalose, Cumberland Pharmaceuticals Inc., September 17, 2018) says: “KRISTALOSE ® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lactulose have a boxed warning?
- No. None of the 25 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lactulose?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lactulose been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lactulose?
- 21 companies list prescription products of Lactulose in the FDA NDC Directory, including PAI Holdings, LLC dba PAI Pharma, Chartwell RX, LLC and Trifluent Pharma, Inc..
What Lactulose is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KRISTALOSE ® (LACTULOSE) For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.
— FDA label: Kristalose, Cumberland Pharmaceuticals Inc., effective September 17, 2018. Read the full label on DailyMed →
The FDA has 25 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 25 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Powder, for solution |
|---|---|
| Route | Oral · Rectal |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Kristalose, Lactulose Crystalline, Enulose, Constulose, Generlac |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lactulose 10 g/10 g powder, for solution | Generic | $8.27 per unit |
| lactulose 10 g/10 g powder, for solution | Brand: Kristalose | $9.58 per unit |
| lactulose 10 g/15 mL solution | Generic | $0.0126–$0.0210 per mL 22 packages, lowest to highest |
| lactulose 20 g/20 g powder, for solution | Generic | $8.67 per unit |
| lactulose 20 g/20 g powder, for solution | Brand: Kristalose | $9.92 per unit |
| lactulose 20 g/30 mL solution | Generic | $0.0512 per mL |
NADAC list of November 4, 2026; these prices took effect between February 18, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- PAI Holdings, LLC dba PAI Pharma6 products
- Chartwell RX, LLC4 products
- Trifluent Pharma, Inc.2 products
- Apozeal Pharmaceuticals Inc2 products
- Actavis Pharma, Inc.2 products
- Cumberland Pharmaceuticals Inc.2 products
- Kesin Pharma Corporation2 products
- Cumberland Assured Products Inc.2 products
- Chartwell Governmental & Specialty RX, LLC.2 products
- Foxland Pharmaceuticals, Inc.2 products
- Rising Pharma Holdings, Inc.1 product
- Cardinal Health 107, LLC1 product
- Fresenius Kabi Austria GmbH1 product
- Xttrium Laboratories, Inc.1 product
- Bajaj Medical, LLC1 product
- Lannett Company, Inc.1 product
- Atlantic Biologicals Corp.1 product
- Proficient Rx LP1 product
- Sun Pharmaceutical Industries, Inc.1 product
- American Health Packaging1 product
- Bryant Ranch Prepack1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (13)
- ANDA074623Pharm Assoc · July 30, 1996
- ANDA074603Chartwell Rx · October 31, 1996
- ANDA074712Apotex · December 10, 1997
- ANDA075993Lannett Co Inc · July 26, 2001
- ANDA075911Pharmobedient · February 21, 2002
- ANDA076645Bajaj · July 28, 2003
- ANDA090502Fresenius Kabi · January 25, 2012
- ANDA090503Fresenius Kabi · January 25, 2012
- ANDA203762Pharmazone · March 27, 2015
- ANDA207786Pharmazone · June 11, 2018
- ANDA209517Chartwell Rx · November 23, 2018
- ANDA218858Taro · December 13, 2024
- ANDA217914Pai Holdings · March 14, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Kristalose, Cumberland Pharmaceuticals Inc., effective September 17, 2018; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →