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LACTULOSE 10 g/15mL Solution — NDC 00121-4577-50 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 0121-4577-50 (Billing 00121-4577-50)

by PAI Holdings, LLC dba PAI Pharma · 5 TRAY in 1 CASE / 5 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE

This is a package of LACTULOSE 10 g/15mL Solution from PAI Holdings, LLC dba PAI Pharma, marketed since Jul 1966 and currently FDA-listed.

NDC 00121-4577-50
🏷️ FDA NDC (as labeled) 0121-4577-50 billing pads the labeler segment with a zero
This package
Contains15 mL in 1 cup, unit-dose Pack sizes3 compare ↓
Also priced by: Part D plans $0.0465/unit — full pricing hub ↓
Product page 00121-4577-06 Also comes in: 10 cups 0121-4577-40 16 cups 0121-4577-06
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0121-4577-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0121 labeler · 4577 product · 50 package
Package marketed since
Nov 19, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0121457750 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-4577-50
Product NDC 0121-4577
11-digit billing NDC 00121457750
RxCUI 391937
UNII 9U7D5QH5AE
Application # ANDA074623
SPL Set ID 0f19e4ed-c90a-4330-a7fa-bf911aa98f09
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 1966-07-30
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 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 0121-4577-50 — 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 → 00121-4577-50. 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 $17.44 / 375 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
00121-4577-06 0121-4577-06 Main listing 6 CARTON in 1 CASE / 16 CUP, UNIT-DOSE in 1 CARTON / 15 mL in 1 CUP, UNIT-DOSE 2019-05-03 — Discontinued by firm
00121-4577-40 0121-4577-40 4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE 1966-07-30 — Active
00121-4577-50 You're viewing this 5 TRAY in 1 CASE / 5 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE 2022-11-19 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 tray in 1 case / 5 cup, unit-dose in 1 tray / 15 ml in 1 cup, unit-dose.
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.

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/15mLthis 00121-4577-50 PAI 5 cups — AA FDA listed —
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

🏛️
1966
On the market since
Jul 1966
📍
2026
Currently FDA-listed
60 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.

What it looks like

Color yellow
FlavorPineapple
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.

🧪 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.

  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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.

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 marketedJul 1966
Product typeHuman Prescription Drug
Portfolio142 products on file

More NDCs from PAI Holdings, LLC dba PAI Pharma labeler code 00121

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 54 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 Pharmaceutical Associates, Inc. at 1-800-845-8210.

🔄 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 77 words ▾

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 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 NDC 0121-0577-08: 8 fl oz (237 mL) bottles NDC 0121-0577-16: 16 fl oz (473 mL) bottles NDC 0121-0577-32: 32 fl oz (946 mL) bottle NDC 0121-4577-15: 15 mL unit dose cup NDC 0121-4577-40: Case contains 40 unit dose cups of 15 mL (0121-4577-15) packaged in 4 trays of 10 unit dose cups each. NDC 0121-4577-06: Case contains 96 unit dose cups of 15 mL (0121-4577-15) packaged in 6 cartons of 16 unit dose cups each. NDC 0121-1154-30: 30 mL unit dose cup NDC 0121-1154-40: Case contains 40 unit dose cups of 30 mL (0121-1154-30) packaged in 4 trays of 10 unit dose cups each.

NDC 0121-1154-00: Case contains 100 unit dose cups of 30 mL (0121-1154-30) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1154-06: Case contains 96 unit dose cups of 30 mL (0121-1154-30) packaged in 6 cartons of 16 unit dose cups each. Lactulose solution contains lactulose 667 mg/mL (10 g/15 mL).

Store at controlled room temperature, 20°-25°C (68°-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. Keep tightly closed. 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.

📦 Storage and Handling 121 words ▾

Store at controlled room temperature, 20°-25°C (68°-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. Keep tightly closed. 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.

📋 Description 98 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 FD&C Yellow No.

6, purified water, and flavoring. Sodium hydroxide used to adjust pH. The pH range is 2.5 to 6.5.

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. 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 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 204 words ▾

PRINCIPAL DISPLAY PANEL - 15 mL Cup Lid UNIT DOSE Delivers 15 mL NDC 0121-4577-15 L ACTULOSE S OLUTION USP 10 g/15 mL Indication: For the treatment of constipation. See Insert. FOR INSTITUTIONAL USE ONLY Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 F45771500 PRINCIPAL DISPLAY PANEL - 15 mL Cup Lid

PRINCIPAL DISPLAY PANEL - 30 mL Cup Lid - NDC 0121-1154-30 UNIT DOSE Delivers 30 mL NDC 0121-1154-30 L ACTULOSE S OLUTION USP 20 g/30 mL Indication: For the treatment of constipation. See Insert. FOR INSTITUTIONAL USE ONLY Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 A45773001 PRINCIPAL DISPLAY PANEL - 30 mL Cup Lid - NDC 0121-1154-30

PRINCIPAL DISPLAY PANEL -116 oz bottle 0121-0577-16 NDC 0121-0577-16 LACTULOSE Solution USP 10g/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). Also contains FD&C Yellow No. 6, purified water, and flavoring.

Sodium hydroxide used to adjust pH. The pH range is 2.5 to 6.5.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.

16 oz bottle label

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) ✓ 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 PAI Holdings, LLC dba PAI Pharma. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 cups (00121-4577-40), 16 cups (00121-4577-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
PAI Holdings, LLC dba PAI Pharma 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.
← 00121-4067-40 · PAI 00121-4675-00 · 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.