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Lactulose 10 g/15mL Solution — NDC 68999-0002-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lactulose 10 g/15mL Solution — NDC 68999-002-24 (Billing 68999-0002-24)

by Chartwell Governmental & Specialty RX, LLC. · 2 TRAY in 1 BOX / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE

This is a package of Lactulose 10 g/15mL Solution from Chartwell Governmental & Specialty RX, LLC., marketed since Nov 2018 and currently FDA-listed. It is this product's only package size.

NDC 68999-0002-24
🏷️ FDA NDC (as labeled) 68999-002-24 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68999-002-24
Product NDC 68999-002
11-digit billing NDC 68999000224
NCPDP billing unit ML — per mL (volume)
RxCUI 391937
UNII 9U7D5QH5AE
Application # ANDA209517
SPL Set ID 887157ba-3c91-4fbf-bb12-b49c6fa4252c
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity; Acidifying Activity
Physiologic effect Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-23
Route ORAL
Dosage form SOLUTION
Substance LACTULOSE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 46600020002010
GCN Seq No 029054
GCN 10167
HICL code 001396
Ingredient (HICL) Lactulose
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 40:10.00.00
AHFS class Ammonia Detoxicants
FDB label name LACTULOSE 10 GM/15 ML SOLN CUP
FDB brand name Lactulose
Legend status F — Federal legend — prescription drug or device
Quick answers
  • 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
Why two NDCs? The FDA registers this code as 68999-002-24 — a 5-3-2 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 product segment → 68999-0002-24. 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 class Osmotic Laxative
Drug family (ATC) Osmotically acting laxatives
How it works Osmotic 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.

Clinical

Label name LACTULOSE 10 GM/15 ML SOLN CUP Ingredient Lactulose
📖 What it is MedlinePlus · NLM

Lactulose is a synthetic sugar used to treat constipation. It is broken down in the colon into products that pull water out from the body and into the colon. This water softens stools. Lactulose is also used to reduce the amount of ammonia in the blood of patients with liver disease. It works by drawing ammonia from the blood into the colon where it is removed from the body. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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...
📖 Read our full Lactulose guide →
Where does this data come from?
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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.0465 $13.95 / 300 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68999-0002-24 You're viewing this Main listing 2 TRAY in 1 BOX / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE 2025-10-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lactulose Solution 10 g/15mL 81033-0241-32 Kesin 946 ml $0.013 AA Availability likely —
Enulose 10 g/15mL 45963-0438-64 Actavis 473 ml $0.013 AA Availability likely —
Generlac 10 g/15mL 62135-0892-47 Chartwell 473 ml $0.013 AA Availability likely —
Lactulose 10 g/15mL 00116-4005-08 Xttrium 237 ml $0.019 AA Availability likely —
Constulose 10 g/15mL 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 —
Lactulose 10 g/15mL 51672-4243-09 Sun 1 bottle $0.022 AA Availability likely —
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/15mLthis 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 —
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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 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.

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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

Manufacturer & labeler

LabelerChartwell Governmental & Specialty RX, LLC.
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA209517 (ANDA)
Labeler code68999
First marketedNov 2018
Product typeHuman Prescription Drug
Portfolio33 products on file
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.

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

INDICATION 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 68 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.

⛔ Contraindications 22 words ▾

CONTRAINDICTIONS Since lactulose solution contains galactose (less than 1.6 g/15 mL), it is contraindicated in patients who require a low galactose diet.

⚠️ Warnings 91 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 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 63 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 Chartwell Governmental & Specialty RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 81 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 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 161 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 Handling 166 words ▾

HOW SUPPLIED Lactulose Solution is a colorless to amber syrupy liquid. It is available in 15 mL Unit Dose Cups (NDC 68999-002-51) 20 Unit Dose Cups of 15 mL each (NDC 68999-002-24) 30 mL Unit Dose Cups (NDC 68999-004-43) 20 Unit Dose Cups of 30 mL each (NDC 68999-004-24) Lactulose Solution USP contains 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 semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.

Manufactured for: Chartwell Governmental & Specialty RX, LLC. Congers, NY 10920 L72781 Rev: 10/2025

📋 Description 96 words ▾

DESCRIPTION Lactulose is a synthetic disaccharide in solution form for oral administration. Each 15 mL of lactulose solution 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.

The pH range is 2.5 to 6.5. Lactulose is a colonic acidifier which promotes laxation. The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.

The molecular formula is C 12 H 22 O 11 . It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water. "Image Description"

⚠️ Precautions ~1 min read ▾

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 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.

📄 Package Label / Principal Display Panel 36 words ▾

Lactulose Oral Solution, USP 10 g/15 mL - NDC 68999-002-51 - 15 mL Unit Dose Cup Lactulose Oral Solution, USP 20 g/30 mL - NDC 68999-004-43 - 30 mL Unit Dose Cup "Image Description" "Image Description"

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Chartwell Governmental & Specialty RX, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chartwell Governmental & Specialty RX, LLC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68998-0939-30 · Marc 68999-0004-24 · Chartwell →
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.