Mechanism of actionOsmotic Activity; Acidifying Activity
Physiologic effectStimulation Large Intestine Fluid/Electrolyte Secretion
DEA scheduleNon-controlled
Marketing categoryANDA
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2022-07-01
RouteORAL
Dosage formSOLUTION
SubstanceLACTULOSE
GPI-1446600020002010
GCN Seq No029054
GCN10167
HICL code001396
Ingredient (HICL)Lactulose
HIC1 codeD
Therapeutic class — broad (HIC1)Biliary System/Gastro-Intestinal System
HIC2 codeD6
Therapeutic class — intermediate (HIC2)Drugs Acting Principally On The Colon
HIC3 codeD6S
Therapeutic class — specific (HIC3)Laxatives And Cathartics
AHFS code40:10.00.00
AHFS classAmmonia Detoxicants
FDB label nameLACTULOSE 10 GM/15 ML SOLUTION
FDB brand nameLactulose
Legend statusF — Federal legend — prescription drug or device
TE code (Orange Book)AA · RLD · RS
Why two NDCs?
The FDA registers this code as 0116-4005-16 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00116-4005-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
Pharmacologic classOsmotic Laxative
Drug family (ATC)Osmotically acting laxatives
How it worksOsmotic Activity, Acidifying Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name LACTULOSE 10 GM/15 ML SOLUTIONIngredient Lactulose
📗 Our plain-language guide HelloPharmacist
Lactulose has two main uses. Some products — like Constulose and Kristalose — are prescribed specifically for constipation. Other products, like Enulose and Generlac, are used for...
For constipation, it usually takes 24 to 48 hours to produce a bowel movement, so don't be worried if nothing happens right away. For portal-systemic encephalopathy, improvement ma...
How long does it take lactulose to work?
The most common side effects are digestive — gas, bloating, belching, and mild stomach cramping. These are pretty typical, especially when you first start. The one to watch for is...
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Lactulose?
Ask a licensed pharmacist directly — free, answered by our team.
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product
other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors,
or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
Price system
Per mL
Per package
Retail pharmacies payNADAC · weekly
$0.022
$10.60 / 473 ml
Medicaid paysCMS SDUD · 12 mo
$0.0303
$14.33 / 473 ml
Medicare drug plans payPart D · Q2 2026
$0.0465
$21.99 / 473 ml
NADAC price history (per mL) — tap or hover for the price & month
▲ Up 78% over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00116-4005-16, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
99.7K
Units reimbursed last 4 qtrs
73.5M
Gross reimbursed last 4 qtrs
$2.23M
Avg / prescription
$22.34
Avg / unit
$0.0303
Latest quarter Q1 2026
24.7KRx
Medicaid pays / mL
$0.0303
gross reimbursed
vs
NADAC / mL
$0.0224
acquisition cost
=
Spread
+$0.0079
+35% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
45% FFS55% MCO
Fee-for-service · 44,356 Rx Managed care · 55,316 Rx
State Medicaid map
Units reimbursed · per 100k residents
8,50489,255
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1South Dakota89,255 /100k
2Iowa53,727 /100k
3D.C.47,502 /100k
4Louisiana43,647 /100k
5Kentucky41,272 /100k
6Connecticut38,756 /100k
7New Mexico38,060 /100k
8Maine35,885 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 142,410 Rx · 107,557,290 units · $3,124,738 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Lactulose — the program that covers self-administered drugs. 11 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lactulose. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$15.3M
Claims incl. refills
405.5K
Beneficiaries
246.1K
Spend / beneficiary
$62.17
Spend / claim
$37.73
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lactulose — the ingredient across all brands.
Top reported reactions
Nausea2,627
Constipation2,569
Fall2,304
Vomiting2,143
Fatigue2,099
Death2,002
Diarrhoea1,968
Age at onset
Neonate27
Infant36
Child110
Adolescent58
Adult2,768
Elderly2,989
Reporter sex
Male · 48%
Female · 52%
Unknown · 0%
Serious outcomes
Hospitalization20,956
Death6,667
Life-threatening2,984
Disabling1,254
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
Per mL, this pack runs about 15% above the cheapest pack (946 mL, $0.0194 vs $0.0224 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 70% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00116-4005-16?
NDC 00116-4005-16 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 00116-4005-16 and NDC 00116-4005-15?
Both are Lactulose 10 g/15mL Solution — the drug itself is identical. NDC 00116-4005-16 is the 473 mL package, while NDC 00116-4005-15 is the 15 ml package.
What NDC number is used to bill for this package of Lactulose 10 g/15mL Solution?
Bill NDC 00116-4005-16 — the 11-digit billing format is 00116400516. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
INDICATIONS AND USAGE For 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.
⏱️Dosage and Administration68 words▾
DOSAGE AND ADMINISTRATION The usual dose is 1 to 2 tablespoonfuls (15 to 30 mL, containing 10 g to 20 g of lactulose) daily. The dose may be increased to 60 mL daily if necessary. Twenty-four to 48 hours may be required to produce a normal bowel movement. NOTE: Some patients have found that lactulose solution may be more acceptable when mixed with fruit juice, water, or milk.
⛔Contraindications22 words▾
CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
⚠️Warnings90 words▾
WARNINGS A theoretical hazard may exist for patients being treated with lactulose solution who may be required to undergo electrocautery procedures during proctoscopy or colonoscopy. Accumulation of H2 gas in significant concentration in the presence of an electrical spark may result in an explosive reaction. Although this complication has not been reported with lactulose, patients on lactulose therapy undergoing such procedures should have a thorough bowel cleansing with a non-fermentable solution.
Insufflation of CO 2 as an additional safeguard may be pursued but is considered to be a redundant measure.
🤒Adverse Reactions60 words▾
ADVERSE REACTIONS Precise frequency data are not available. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia, and hypernatremia. Nausea and vomiting have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄Drug Interactions50 words▾
Drug Interactions Results of preliminary studies in humans and rats suggest that non-absorbable antacids given concurrently with lactulose may inhibit the desired lactulose-induced drop in colonic pH. Therefore, a possible lack of desired effect of treatment should be taken into consideration before such drugs are given concomitantly with lactulose solution.
🤰Pregnancy75 words▾
Pregnancy Teratogenic Effects Reproduction studies have been performed in mice, rats, and rabbits at doses up to 3 or 6 times the usual human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to lactulose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
🧒Pediatric Use12 words▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘Overdosage76 words▾
OVERDOSAGE Signs and Symptoms There have been no reports of accidental overdosage. In the event of overdosage, it is expected that diarrhea and abdominal cramps would be the major symptoms. Medication should be terminated.
Oral LD50 The acute oral LD50 of the drug is 48.8 mL/kg in mice and greater than 30 mL/kg in rats. Dialysis Dialysis data are not available for lactulose. Its molecular similarity to sucrose, however, would suggest that it should be dialyzable.
🧬Clinical Pharmacology161 words▾
CLINICAL PHARMACOLOGY Lactulose is poorly absorbed from the gastrointestinal tract and no enzyme capable of hydrolysis of this disaccharide is present in human gastrointestinal tissue. As a result, oral doses of lactulose reach the colon virtually unchanged. In the colon, lactulose is broken down primarily to lactic acid, and also to small amounts of formic and acetic acids, by the action of colonic bacteria, which results in an increase in osmotic pressure and slight acidification of the colonic contents.
This in turn causes an increase in stool water content and softens the stool. Since lactulose does not exert its effect until it reaches the colon, and since transit time through the colon may be slow, 24 to 48 hours may be required to produce the desired bowel movement. Lactulose given orally to man and experimental animals resulted in only small amounts reaching the blood.
Urinary excretion has been determined to be 3% or less and is essentially complete within 24 hours.
📦How Supplied / Storage and Handling218 words▾
HOW SUPPLIED Lactulose Solution, USP 10 g/15 mL is a colorless to yellow, unflavored solution available in the following container sizes: 15 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-15) 30 mL unit dose white cups in trays of 10 cups (NDC 0116-4005-30) 8 fl. oz. (237 mL) white bottles (NDC 0116-4005-08) 16 fl. oz. (473 mL) white bottles (NDC 0116-4005-16) 32 fl. oz.
(946 mL) white bottles (NDC 0116-4005-32) Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL). Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. Do not freeze.
Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 30 °C (86 °F) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable.
If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semisolid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.
Dispense in original container or in a tight, light-resistant container as defined in the USP, with a child-resistant closure. To The Pharmacist: When ordering this product, include the product number (or NDC) in the description.
📋Description101 words▾
DESCRIPTION Lactulose solution is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose contains : 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 1.2 g or less of other sugars). Also contains water, D&C Yellow No.
10, and FD&C Yellow No. 6. The pH range is 2.5 to 6.5.
Lactulose solution is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula: C 12 H 22 0 11 The molecular weight is 342.30.
It is freely soluble in water. structure
💬Information for Patients15 words▾
Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
contraindicated: Should not be used in that situation, because the risk is considered too high.
accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
diarrhea: Loose, watery bowel movements that happen more often than normal.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.
Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.
fertility: The natural ability to become pregnant or to father a child.
flatulence: Passing gas from the bowel; feeling bloated or gassy.
hypernatremia: A higher-than-normal level of sodium (salt) in the blood.
hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.
Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.
teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.
