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LACTULOSE 10 g/15mL Solution, 946 mL — NDC 00121-0873-32 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, 946 mL — NDC 0121-0873-32 (Billing 00121-0873-32)

by PAI Holdings, LLC dba PAI Pharma · 946 mL in 1 BOTTLE

This is a package of 946 mL of LACTULOSE 10 g/15mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Dec 2019 and currently FDA-listed; retail pharmacies pay about $0.0194 per mL (NADAC).

NDC 00121-0873-32
🏷️ FDA NDC (as labeled) 0121-0873-32 billing pads the labeler segment with a zero
This package
Contains946 mL Cost per mL$0.0194 NADAC Per package$18.35 / 946 ml Pack sizes6 compare ↓
Also priced by: Medicaid pays $0.0260/unit · Part D plans $0.0465/unit — full pricing hub ↓
Product page 00121-0873-16 Also comes in: 10 cups 0121-0873-40 15 ml 0121-0873-15 16 cups 0121-0873-06 237 ml 0121-0873-08 473 ml 0121-0873-16
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) 0121-0873-32
Product NDC 0121-0873
11-digit billing NDC 00121087332
NCPDP billing unit ML — per mL (volume)
RxCUI 391937
UNII 9U7D5QH5AE
Application # ANDA074623
SPL Set ID cbf0497c-9c8d-4dfa-bebd-64c589468401
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 2019-12-03
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
GPI class Lactulose
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 SOLUTION
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 0121-0873-32 — 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 → 00121-0873-32. 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 SOLUTION Ingredient Lactulose
📗 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 $0.019 $18.35 / 946 ml
Medicaid paysCMS SDUD · 12 mo $0.0260 $24.60 / 946 ml
Medicare drug plans payPart D · Q2 2026 $0.0465 $43.99 / 946 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.020 $0.012
▲ Up 44% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00121-0873-06 0121-0873-06 6 CARTON in 1 CASE / 16 CUP, UNIT-DOSE in 1 CARTON / 15 mL in 1 CUP, UNIT-DOSE — — 2019-12-03 — Active
00121-0873-08 0121-0873-08 237 mL in 1 BOTTLE — — 2019-12-03 — Discontinued by firm
00121-0873-16 0121-0873-16 Main listing 473 mL in 1 BOTTLE $0.0224 / mL $10.58 2019-12-03 — Active
00121-0873-32 You're viewing this 946 mL in 1 BOTTLE $0.0194 / mL $18.34 2019-12-03 — Active
00121-0873-40 0121-0873-40 4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE — — 2019-12-03 — Active
00121-0873-15 0121-0873-15 15 mL in 1 CUP, UNIT-DOSE — — 2019-12-03 — Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.0194 NADAC).

This pack accounts for about 7.9% of this product's recent Medicaid fills; most go to the 473 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 946 mL — 946 ml in 1 bottle.
How does this package differ from NDC 00121-0873-15?
Both are LACTULOSE 10 g/15mL Solution — the drug itself is identical. This page's package is the 946 mL one, while NDC 00121-0873-15 is the 15 ml package.
What NDC number is used to bill for this package of LACTULOSE 10 g/15mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/15mLthis 00121-0873-32 PAI 946 ml $0.019 AA Availability likely —
Lactulose 10 g/15mL 00116-4005-08 Xttrium 237 ml $0.019 AA Availability likely +0%
Constulose 10 g/15mL 45963-0439-63 Actavis 237 ml $0.019 AA Availability likely +0%
Lactulose 10 g/15mL 83745-0405-08 APOZEAL 237 ml $0.019 AA Availability likely +0%
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 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 —
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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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

LabelerPAI Holdings, LLC dba PAI Pharma
Application holderPHARMACEUTICAL ASSOCIATES INC
FDA applicationANDA074623 (ANDA)
Labeler code00121
First marketedDec 2019
Product typeHuman Prescription Drug
Portfolio142 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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

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 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 ▾

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 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 60 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 PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 50 words ▾

Drug Interactions Results of preliminary studies in humans and rats suggest that nonabsorbable 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 76 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 Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🆘 Overdosage 78 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 163 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 solution 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 solution 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 ~1 min read ▾

HOW SUPPLIED Lactulose Solution, USP 10g/15 mL is supplied as: NDC 0121-0873-08: 8 fl oz (237 mL) bottles NDC 0121-0873-16: 16 fl oz (473 mL) bottles NDC 0121-0873-32: 32 fl oz (946 mL) bottles NDC 0121-0873-15: 15 mL unit dose cup. Case contains 40 unit dose cups of 15 mL (NDC 0121-0873-40), packaged in 4 trays of 10 unit-dose cups each and 96 unit dose cups of 15 mL (NDC 0121-0873-06) packaged in a carton of 16 unit dose cups each. NDC 0121-1746-30: 30 mL unit dose cup.

Case contains 40 unit dose cups of 30 mL (NDC 0121-1746-40), packaged in 4 trays of 10 unit-dose cups each, 100 unit dose cups of 30 mL (NDC 0121-1746-00), packaged in 10 trays of 10 unit-dose cups each and 96 unit dose cups of 30 mL (NDC 0121-1746-06) packaged in a carton of 16 unit dose cups each. Store at controlled room temperature, 20°to 25°C (68° to 77°F). [See USP] 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 with a child-resistant closure.

To the Pharmacist: When ordering this product, include the NDC number in the description.

📦 Storage and Handling 121 words ▾

Store at controlled room temperature, 20°to 25°C (68° to 77°F). [See USP] 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 with a child-resistant closure. To the Pharmacist: When ordering this product, include the NDC number in the description.

📋 Description 75 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). Lactulose is a colonic acidifier which promotes laxation.

The chemical name for lactulose is 4-0-ß-D-galactopyranosyl-D-fructofuranose. It has the following structural formula: The molecular weight is 342.30. It is freely soluble in water.

Chemical Structure

💬 Information for Patients 15 words ▾

Information for Patients In the event that an unusual diarrheal condition occurs, contact your physician.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Since lactulose solution contains galactose (less than1.6 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 solution 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 nonabsorbable 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 in 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.

🍼 Nursing Mothers 35 words ▾

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 85 words ▾

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 in 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 214 words ▾

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0873-16 Lactulose Solution USP 10 g/15 mL Each 15 mL 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). Dispense in original container or tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the product number (or NDC) in the description.

Rx ONLY 16 fl oz (473 mL) PAI Pharma 16 oz botttle label

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label NDC 0121-0873-32 Lactulose Solution USP 10 g/15 mL Each 15 mL 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). Dispense in original container or tight, light-resistant container with a child-resistant closure. To the Pharmacist: When ordering this product, include the product number (or NDC) in the description.

Rx ONLY 32 fl oz (946 mL) PAI Pharma 32 oz Bottle label

PRINCIPAL DISPLAY PANEL - 30 mL Cup Lid - NDC 0121-1746-30 UNIT DOSE Delivers 30 mL NDC 0121-1746-30 LACTULOSE SOLUTION USP 20 g/30 mL Indication: For the treatment of constipation. See Insert. Package Not Child-Resistant Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 30 mL UDC cup lidding

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

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 this package alone, 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
27.1K
Units reimbursed last 4 qtrs
27.9M
Gross reimbursed last 4 qtrs
$726.7K
Avg / prescription
$26.81
Avg / unit
$0.0260
Latest quarter Q1 2026
9.3KRx
Medicaid pays / mL
$0.0260
gross reimbursed
vs
NADAC / mL
$0.0194
acquisition cost
=
Spread
+$0.0066
+34% 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 ⓘ
44% FFS 56% MCO
Fee-for-service · 11,944 Rx Managed care · 15,166 Rx
State Medicaid map
Alaska: 104,451 units · 14,250 per 100k residents AK Maine: 142,387 units · 10,207 per 100k residents ME Washington: 428,528 units · 5,486 per 100k residents WA Idaho: 180,148 units · 9,173 per 100k residents ID Montana: 67,026 units · 5,921 per 100k residents MT North Dakota: 75,002 units · 9,579 per 100k residents ND Minnesota: 239,012 units · 4,166 per 100k residents MN Wisconsin: 224,562 units · 3,800 per 100k residents WI Michigan: 565,159 units · 5,631 per 100k residents MI New York: 1,929,815 units · 9,861 per 100k residents NY Vermont: 27,246 units · 4,211 per 100k residents VT New Hampshire: 55,727 units · 3,975 per 100k residents NH Oregon: 352,008 units · 8,316 per 100k residents OR Nevada: 180,872 units · 5,663 per 100k residents NV Wyoming: no data reported WY South Dakota: 33,736 units · 3,671 per 100k residents SD Iowa: 136,259 units · 4,249 per 100k residents IA Illinois: 137,930 units · 1,099 per 100k residents IL Indiana: 440,636 units · 6,421 per 100k residents IN Ohio: 933,291 units · 7,919 per 100k residents OH Pennsylvania: 1,144,511 units · 8,830 per 100k residents PA New Jersey: 506,231 units · 5,449 per 100k residents NJ Massachusetts: 945,205 units · 13,501 per 100k residents MA California: 4,174,670 units · 10,714 per 100k residents CA Utah: 69,193 units · 2,025 per 100k residents UT Colorado: 239,027 units · 4,066 per 100k residents CO Nebraska: 104,721 units · 5,294 per 100k residents NE Missouri: 852,231 units · 13,755 per 100k residents MO Kentucky: 975,885 units · 21,562 per 100k residents KY West Virginia: 668,431 units · 37,764 per 100k residents WV Virginia: 823,095 units · 9,443 per 100k residents VA Maryland: 507,320 units · 8,209 per 100k residents MD Connecticut: 394,369 units · 10,903 per 100k residents CT Rhode Island: 73,821 units · 6,742 per 100k residents RI Arizona: 313,708 units · 4,222 per 100k residents AZ New Mexico: 871,990 units · 41,248 per 100k residents NM Kansas: 51,697 units · 1,758 per 100k residents KS Arkansas: 377,378 units · 12,304 per 100k residents AR Tennessee: 411,134 units · 5,769 per 100k residents TN North Carolina: 757,310 units · 6,989 per 100k residents NC South Carolina: 288,063 units · 5,361 per 100k residents SC Delaware: 39,628 units · 3,844 per 100k residents DE Oklahoma: 519,923 units · 12,828 per 100k residents OK Louisiana: 461,973 units · 10,100 per 100k residents LA Mississippi: 243,129 units · 8,270 per 100k residents MS Alabama: 451,370 units · 8,837 per 100k residents AL Georgia: 424,818 units · 3,852 per 100k residents GA D.C.: 349,221 units · 51,432 per 100k residents DC Hawaii: no data reported HI Texas: 2,233,164 units · 7,321 per 100k residents TX Florida: 2,300,932 units · 10,177 per 100k residents FL
Units reimbursed · per 100k residents
1,09951,432
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
🏆 Top states by units · per 100k residents
1 D.C. 51,432 /100k
2 New Mexico 41,248 /100k
3 West Virginia 37,764 /100k
4 Kentucky 21,562 /100k
5 Alaska 14,250 /100k
6 Missouri 13,755 /100k
7 Massachusetts 13,501 /100k
8 Oklahoma 12,828 /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.
473 ml00121-0873-16 315,435 Rx · $7,217,456
946 ml this page00121-0873-32 27,110 Rx · $726,745
237 ml00121-0873-08 79 Rx · $1,371
16 cups00121-0873-06 No Medicaid data
10 cups00121-0873-40 No Medicaid data
15 ml00121-0873-15 No Medicaid data
Drug total (last 4 qtrs): 342,624 Rx · 268,980,922 units · $7,945,572 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.
← 00121-0868-00 · PAI 00121-0874-04 · PAI →
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.