Quick answers
- What is LACTULOSE Crystalline?
- LACTULOSE Crystalline is a brand name of Lactulose, a prescription medicine. The FDA NDC Directory lists 2 LACTULOSE Crystalline products in 2 strengths and forms.
- Who makes LACTULOSE Crystalline?
- Apotex holds the FDA application for LACTULOSE Crystalline (ANDA074712, approved December 10, 1997).
- Is there a generic or store brand of LACTULOSE Crystalline?
- Yes. The FDA NDC Directory lists 6 other products with the same active ingredients, strength and form as a LACTULOSE Crystalline product, 6 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for LACTULOSE Crystalline?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 LACTULOSE Crystalline strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has LACTULOSE Crystalline been recalled?
- No recall linked to LACTULOSE Crystalline products (by their NDC code or label) appears in the FDA enforcement reports we use.
What LACTULOSE Crystalline is
Each LACTULOSE Crystalline product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Lactulose · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| lactulose 10 g/10 g powder, for solution (oral) | LACTULOSE Crystalline | 3 products, 3 companies | DailyMed |
| lactulose 20 g/20 g powder, for solution (oral) | LACTULOSE Crystalline | 3 products, 3 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Lactulose →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA074712 | Apotex | December 10, 1997 | 2 |
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: LACTULOSE Crystalline | $8.27 per unit Generic of the same strength and form: $8.27 per unit |
| lactulose 20 g/20 g powder, for solution | Generic: LACTULOSE Crystalline | $8.67 per unit Generic of the same strength and form: $8.67 per unit |
NADAC list of November 4, 2026; these prices took effect on 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 LACTULOSE Crystalline
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of LACTULOSE Crystalline products.
- Cumberland Assured Products Inc.2 products
Recalls
No recall linked to LACTULOSE Crystalline products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.