Constulose Lactulose 10 g/15mL Solution, 237 mL — NDC 45963-439-63 (Billing 45963-0439-63)
This is a package of 237 mL of Constulose Lactulose 10 g/15mL Solution from Actavis Pharma, Inc., marketed since Feb 2011 and currently FDA-listed; retail pharmacies pay about $0.0195 per mL (NADAC).
NDC database record
One package, one record: these facts belong to NDC 45963-439-63 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 45963 labeler · 439 product · 63 package
- Package marketed since
- Feb 28, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 237 mL per package
- Barcode (UPC-A, from the NDC)
- 3 4596343963 5
- Medicaid fills, this package
- 24,774 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 029054
- GCN: 10167
- GPI-14 (Medi-Span): 46600020002010
- HICL (First Databank): 001396
- AHFS class code: 40:10.00.00
- RxCUI (RxNorm): 391937
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It depends on the product. Some, like Generlac and Enulose, prevent and treat portal-systemic encephalopathy, a brain problem tied to liver disease. Others, like Constulose and Kri...
- For constipation, it can take 24 to 48 hours to produce a bowel movement. For encephalopathy, you may improve within 24 hours, but it might not start before 48 hours or later.
- Gas, bloating, belching and cramps are the most common, affecting about 20% of people. Nausea and vomiting can happen. If you get diarrhea, tell your doctor, since the dose may nee...
- Check with me or your doctor first. Other laxatives can mask whether your lactulose dose is working, and nonabsorbable antacids may weaken its effect. Neomycin and similar antibiot...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lactulose — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.020 | $4.62 / 237 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.0304 | $7.20 / 237 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.0386 | $9.15 / 237 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 45963-0439-63 You're viewing this | 237 mL in 1 BOTTLE | $0.0195 / mL | $4.61 | 2011-02-28 | — | Active |
| 45963-0439-65 45963-439-65 Main listing | 946 mL in 1 BOTTLE | $0.0194 / mL | $18.34 | 2011-02-28 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack accounts for about 24% of this product's recent Medicaid fills; most go to the 946 ml pack. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 45963-0439-65?
What NDC number is used to bill for this package of Constulose Lactulose 10 g/15mL Solution?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lactulose Solution 10 g/15mL 81033-0241-32 | Kesin | 946 ml | $0.013 | AA | Availability likely | save 36% |
| Enulose 10 g/15mL 45963-0438-64 | Actavis | 473 ml | $0.013 | AA | Availability likely | save 33% |
| Generlac 10 g/15mL 62135-0892-47 | Chartwell | 473 ml | $0.013 | AA | Availability likely | save 33% |
| Lactulose 10 g/15mL 00116-4005-08 | Xttrium | 237 ml | $0.019 | AA | Availability likely | — |
| Constulose 10 g/15mLthis 45963-0439-63 | Actavis | 237 ml | $0.019 | AA | Availability likely | — |
| Lactulose 10 g/15mL 83745-0405-08 | APOZEAL | 237 ml | $0.019 | AA | Availability likely | — |
| Lactulose 10 g/15mL 62135-0003-37 | Chartwell | 237 ml | $0.020 | AA | Availability likely | +2% |
| Lactulose 10 g/15mL 51672-4243-09 | Sun | 1 bottle | $0.022 | AA | Availability likely | +15% |
| Lactulose 10 g/15mL 00121-0873-06 | PAI | 16 cups | — | AA | FDA listed | — |
| Lactulose 20 g/30mL 00121-1154-06 | PAI | 16 cups | — | AA | Discontinued | — |
| Lactulose 20 g/30mL 00121-1746-00 | PAI | 10 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 00121-4577-06 | PAI | 16 cups | — | AA | Discontinued | — |
| Lactulose 10 g/15mL 00527-5125-68 | Lannett | 237 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 17856-0874-03 | Atlantic | 50 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 18124-0002-16 | Fresenius | 473 ml | — | AA | FDA listed | — |
| Lactulose 20 g/30mL 55154-9448-05 | Cardinal | 5 cups | — | AA | FDA listed | — |
| Lactulose Solution 10 g/15mL 61037-0471-02 | Bajaj | 236 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 62135-0002-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 62135-0004-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Enulose 10 g/15mL 63629-8800-01 | Bryant | 473 ml | — | AA | FDA listed | — |
| Lactulose Solution 10 g/15mL 64980-0592-12 | Rising | 118 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 68999-0002-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Lactulose 20 g/30mL 68999-0004-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 82804-0107-47 | Proficient | 473 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 83745-0249-08 | APOZEAL | 237 ml | — | AA | FDA listed | — |
| Lactulose 10 g/15mL 60687-0917-14 | American | 10 cups | — | AA | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Lactulose inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 6YSS42VSEV
Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
-
UNII X2RN3Q8DNE
Galactose is a simple sugar derived from milk or made through chemical processes. It acts as a filler and sweetener in medicines, helping create the proper tablet size and improving taste.
-
UNII J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Actavis Pharma, Inc. labeler code 45963
- Desipramine Hydrochloride 25 mg Tablet, Film Coated NDC 45963-342-02
- Desipramine Hydrochloride 50 mg Tablet, Film Coated NDC 45963-343-02
- Desipramine Hydrochloride 75 mg Tablet, Film Coated NDC 45963-344-02
- Desipramine Hydrochloride 100 mg Tablet, Film Coated NDC 45963-345-02
- Desipramine Hydrochloride 150 mg Tablet, Film Coated NDC 45963-346-50
- Enulose Lactulose 10 g/15mL Solution NDC 45963-438-64
- Deferasirox 250 mg Tablet, For Suspension NDC 45963-455-30
- Deferasirox 500 mg Tablet, For Suspension NDC 45963-456-30
- Gabapentin 100 mg Capsule NDC 45963-555-00
- Gabapentin 300 mg Capsule NDC 45963-556-00
- Gabapentin 400 mg Capsule NDC 45963-557-00
- Vinorelbine 10 mg/mL Injection, Solution NDC 45963-607-55
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 Administration ▾
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.
⛔ Contraindications ▾
CONTRAINDICATIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.
⚠️ Warnings ▾
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 H 2 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 Reactions ▾
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 EVENTS, contact the FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
🔄 Drug Interactions ▾
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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy category B. 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 Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
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 LD 50 : The acute oral LD 50 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 Pharmacology ▾
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 Handling ▾
HOW SUPPLIED Lactulose Solution, USP is a natural colored and an unflavored solution available in 8 fl oz (237 mL) and 1 quart (946 mL) bottles. Lactulose Solution, USP contains lactulose 670 mg/mL (10 g/15 mL). Store between 36° to 86°F (2° to 30°C).
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 86°F (30°C) 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 semi-solid, too viscous to pour.
Viscosity will return to normal upon warming to room temperature. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured and packaged by: Fresenius Kabi Austria GmbH Estermannstraße 17 4020 Linz, Austria Manufactured for: Teva Pharmaceuticals Parsippany, NJ 07054 USA Revised – June 2022
📋 Description ▾
DESCRIPTION Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution, USP contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, and 0.1 g or less of fructose). Lactulose is a colonic acidifier which promotes laxation.
The chemical name for lactulose is 4-O- β -D-galactopyranosyl-D-fructofuranose. It has the following structural formula: The molecular weight is 342 . 30.
It is freely soluble in water. 3bfff862-figure-01
💬 Information for Patients ▾
Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.
⚠️ Precautions ▾
PRECAUTIONS General Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics. Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician. Laboratory Tests Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically.
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. Carcinogenesis, Mutagenesis, Impairment of Fertility There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility.
There are no known animal data on long-term potential for mutagenicity. Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity. In studies of mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
Pregnancy Teratogenic Effects Pregnancy category B. 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. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lactulose solution is administered to a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility There are no known human data on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility. There are no known animal data on long-term potential for mutagenicity. Administration of lactulose solution in the diet of mice for 18 months in concentrations of 3 and 10 percent (v/w) did not produce any evidence of carcinogenicity.
In studies of mice, rats, and rabbits, doses of lactulose solution up to 6 or 12 mL/kg/day produced no deleterious effects in breeding, conception, or parturition.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 45963-439-63 Constulose (Lactulose Solution, USP) 10g/15mL For Oral Administration Rx only 8 fl oz (237 mL) image