Medicine guide

Prucalopride

1 mg · Tablet, Film Coated

Prescription only
Serotonin-4 Receptor Agonist

Active substance: Prucalopride
Made by: Amneal Pharmaceuticals NY LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-11-19

What it is

Serotonin-4 Receptor Agonist

Used for

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in

The label’s usual adult dose

Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) [see Use in Specific Populations (8.5 , 8.6) ] . 1 mg once daily Take with or without food.

Full directions ↓

Do not take it if

Prucalopride is contraindicated in patients with:

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

35other products contain Prucalopride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in
adults. Prucalopride is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in
adults. (1)

From the official label · 2025-11-19 · DailyMed

How it works

From this product’s own US prescribing label.

Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility.
Prucalopride was devoid of effects mediated via 5-HT 2A, 5-HT 2B, 5-HT 3, motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater.

Peak level after2 h

Half-life1 day

Mostly cleared after≈ 5 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How it leaves the body

Following oral administration of radiolabeled prucalopride in healthy subjects, 60% to 65% of the administered dose is excreted unchanged in urine and about 5% in feces.

With food

Effect of Food Concomitant intake with a high-fat meal (1,000 kcal total, 500 kcal from fat) does not influence the oral bioavailability of prucalopride [see Dosage and Administration (2) ].

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-11-19

Do not take it if

Prucalopride is contraindicated in patients with:
A history of hypersensitivity to prucalopride.
Reactions including dyspnea, rash, pruritus, urticaria, and facial edema have been observed [see Adverse Reactions (6.2) ] .
Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum.
Hypersensitivity to prucalopride.
(4) Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract such as Crohn’s disease, ulcerative colitis, and toxic megacolon/megarectum.
(4)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Prucalopride tablets can be taken with or without food.
The recommended dosage by patient population is shown in Table 1.
Table 1:
Recommended Dosage Regimen and Dosage Adjustments by Population Population with CIC Recommended Oral Dose Regimen
Adults 2 mg once daily Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) [see Use in Specific Populations (8.5 , 8.6) ] . 1 mg once daily Take with or without food.
(2) Recommended dosage by patient population:
Population with CIC Recommended Oral Dose Regimen
Adults 2 mg once daily.
(2) Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min) 1 mg once daily.
(2 , 8.5 , 8.6)

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Suicidal Ideation and Behavior:
Monitor patients for suicidal ideation and behavior as well as self-injurious ideation and new-onset or worsening of depression.
Instruct patients to discontinue prucalopride immediately and contact their healthcare provider if they experience any unusual changes in mood or behavior, or they experience emerging suicidal thoughts or behaviors.
(5.1)
5.1 Suicidal Ideation and Behavior In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported.
Postmarketing cases of suicidal ideation and behavior as well as self-injurious ideation and new onset or worsening of depression have been reported within the first few weeks of starting prucalopride [see Adverse Reactions (6.1 , 6.2) ] .
A causal association between treatment with prucalopride and an increased risk of suicidal ideation and behavior has not been established.
Monitor all patients treated with prucalopride for new onset or worsening of depression or the emergence of suicidal thoughts and behaviors.
Counsel patients, their caregivers, and family members of patients to be aware of any unusual changes in mood or behavior and alert the healthcare provider.
Instruct patients to discontinue prucalopride immediately and contact their healthcare provider if they experience any of these symptoms.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to prucalopride during pregnancy.
Healthcare providers are encouraged to register patients by contacting MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) at 1-877-311-8972 or visiting https://mothertobaby.org/pregnancy-studies/ .
Risk Summary Available data from case reports with prucalopride use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes.
In animal reproduction studies, no adverse developmental effects were observed with prucalopride administration during the period of organogenesis to pregnant rats and rabbits at doses up to approximately 390 times and 780 times, respectively, the recommended human dose of 2 mg/day (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In oral embryofetal development studies in rats and rabbits, prucalopride was administered to pregnant animals at doses of 5 mg/kg/day, 20 mg/kg/day, and 80 mg/kg/day throughout the period of organogenesis.
No adverse embryofetal developmental effects were observed in either rats or rabbits up to the highest oral dose of 80 mg/kg/day (about 390 times and 780 times the recommended human dose of 2 mg/day, respectively, based on body surface area).
In an oral pre- and post-natal development study in rats, prucalopride was administered at doses of 5 mg/kg/day, 20 mg/kg/day, and 80 mg/kg/day.
At the 80 mg/kg dose (about 390 times the recommended human dose of 2 mg/day, based on body surface area), a slight decrease in overall survival rate of pups after 7 days was observed, which could be due to maternal toxicity observed at this dose.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to prucalopride during pregnancy.
Healthcare providers are encouraged to register patients by contacting MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) at 1-877-311-8972 or visiting https://mothertobaby.org/pregnancy-studies/ .
Risk Summary Available data from case reports with prucalopride use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes.
In animal reproduction studies, no adverse developmental effects were observed with prucalopride administration during the period of organogenesis to pregnant rats and rabbits at doses up to approximately 390 times and 780 times, respectively, the recommended human dose of 2 mg/day (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In oral embryofetal development studies in rats and rabbits, prucalopride was administered to pregnant animals at doses of 5 mg/kg/day, 20 mg/kg/day, and 80 mg/kg/day throughout the period of organogenesis.
No adverse embryofetal developmental effects were observed in either rats or rabbits up to the highest oral dose of 80 mg/kg/day (about 390 times and 780 times the recommended human dose of 2 mg/day, respectively, based on body surface area).
In an oral pre- and post-natal development study in rats, prucalopride was administered at doses of 5 mg/kg/day, 20 mg/kg/day, and 80 mg/kg/day.
At the 80 mg/kg dose (about 390 times the recommended human dose of 2 mg/day, based on body surface area), a slight decrease in overall survival rate of pups after 7 days was observed, which could be due to maternal toxicity observed at this dose.
8.2 Lactation Risk Summary Prucalopride is present in breast milk (see Data ) .
There are no data on the effects of prucalopride on the breastfed child or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prucalopride and any potential adverse effects on the breastfed child from prucalopride or from the underlying maternal condition.
Data In an open-label study in 8 healthy lactating women in the weaning stage, plasma and milk samples were collected at predose (day 1 and 4), and then 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours (day 4) after a 2 mg dose of prucalopride was administered once daily for 4 days.
Prucalopride is excreted in breast milk with a milk to plasma AUC ratio of 2.65:1; the average amount passed to the infant was estimated to be 1.74 mcg/kg/day, which is about 6% of the maternal dose, adjusted for body weight.
The prucalopride concentration detected in breast milk during weaning may not reflect the prucalopride concentration in breast milk during full milk production.
8.4 Pediatric Use The safety and effectiveness of prucalopride have not been established in pediatric patients.
Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Takeda Pharmaceuticals U.S.A., Inc’s MOTEGRITY (prucalopride) tablets.
However, due to Takeda Pharmaceuticals U.S.A., Inc’s marketing exclusivity rights, this drug product is not labeled with that information.
8.5 Geriatric Use Of the 2,484 patients treated with prucalopride 1 mg or 2 mg once daily in 6 controlled trials of at least 12-week duration in patients with CIC, 15% were 65 years of age and over, and 5% were 75 years of age and over [see Clinical Studies (14) ] .
No overall differences in safety and effectiveness were observed between elderly and younger patients.
In an additional 4-week double-blind, placebo-controlled dose escalation study in 89 elderly nursing home residents with CIC (PRU-USA-26, NCT00627692), no unanticipated safety issues were identified.
Elderly subjects had higher prucalopride exposure compared to younger subjects.
However, the effect of age on the pharmacokinetics of prucalopride appeared to be related to decreased renal function [see Clinical Pharmacology (12.3) ] .
Adjust the dosage in elderly patients based on renal function [see Dosage and Administration (2) , Use in Specific Populations (8.6) ] .
8.6 Renal Impairment No dosage adjustment is required for patients with mild and moderate renal impairment (creatinine clearance at least 30 mL/min, as determined from a 24-hour urine collection in the clinical trial).
Prucalopride is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.
A decreased dosage is recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/min, as determined from a 24-hour urine collection in the clinical trial) [see Dosage and Administration (2) ] .
Avoid prucalopride in patients with end-stage renal disease requiring dialysis [see Clinical Pharmacology (12.3) ] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

An overdose may result in appearance of symptoms from an exaggeration of the known pharmacodynamic effects of prucalopride and includes headache, nausea, and diarrhea.
Specific treatment is not available for prucalopride overdose.
Should an overdose occur, treat symptomatically and institute supportive measures, as required.
Extensive fluid loss from diarrhea or vomiting may require correction of electrolyte disturbances.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of prucalopride have not been established in pediatric patients.
Pediatric information describing a clinical study in which efficacy was not demonstrated is approved for Takeda Pharmaceuticals U.S.A., Inc’s MOTEGRITY (prucalopride) tablets.
However, due to Takeda Pharmaceuticals U.S.A., Inc’s marketing exclusivity rights, this drug product is not labeled with that information.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Of the 2,484 patients treated with prucalopride 1 mg or 2 mg once daily in 6 controlled trials of at least 12-week duration in patients with CIC, 15% were 65 years of age and over, and 5% were 75 years of age and over [see Clinical Studies (14) ] .
No overall differences in safety and effectiveness were observed between elderly and younger patients.
In an additional 4-week double-blind, placebo-controlled dose escalation study in 89 elderly nursing home residents with CIC (PRU-USA-26, NCT00627692), no unanticipated safety issues were identified.
Elderly subjects had higher prucalopride exposure compared to younger subjects.
However, the effect of age on the pharmacokinetics of prucalopride appeared to be related to decreased renal function [see Clinical Pharmacology (12.3) ] .
Adjust the dosage in elderly patients based on renal function [see Dosage and Administration (2) , Use in Specific Populations (8.6) ] .

Quoted from the official label, section “Geriatric Use”.

Side effects

Most common adverse reactions (≥ 2%) are headache, abdominal pain, nausea, diarrhea, abdominal distension, dizziness, vomiting, flatulence, and fatigue.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below represent 2,530 patients (1,251 received prucalopride 2 mg once daily and 1,279 received placebo) with CIC from 6 double-blind, placebo-controlled clinical trials of 12 weeks to 24 weeks in duration.
In these trials overall, patients were primarily female (76%) and white (76%).
The mean age was 47 years (range 17 years to 95 years) [see Clinical Studies (14) ] .
Common Adverse Reactions Table 2 below summarizes the incidence (%) of common adverse reactions occurring in at least 2% of patients with CIC receiving either 2 mg of prucalopride once daily or placebo and at an incidence greater than in the placebo group from the six double-blind placebo-controlled trials described above.
Table 2:
Common Adverse Reactions * in Double-Blind Placebo-Controlled Trials of CIC of at least 12 Weeks Duration Adverse Reaction Prucalopride 2 mg Once Daily N = 1,251 † % Placebo N = 1,279 % Headache 19 9 Abdominal pain ‡ 16 11 Nausea 14 7 Diarrhea 13 5 Abdominal distension 5 4 Dizziness 4 2 Vomiting 3 2 Flatulence 3 2 Fatigue 2 1 * Reported in ≥ 2% of patients receiving prucalopride and a rate higher than patients receiving placebo. † Includes 93 patients who started on prucalopride 1 mg and increased to prucalopride 2 mg. ‡ Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal tenderness, abdominal discomfort, and epigastric discomfort.
Less Common Adverse Reactions Less common adverse reactions occurring in < 2% of patients receiving prucalopride 2 mg once daily include:
Gastrointestinal disorders :
Abnormal gastrointestinal sounds Metabolism and nutrition disorders :
Decreased appetite Nervous system disorders :
Migraine Renal and urinary disorders :
Pollakiuria Diarrhea Of the patients who reported diarrhea, 70% (110 out of 157) reported it in the first week of treatment.
Diarrhea typically resolved within a few days in 73% (80 out of 110) of those patients.
Severe diarrhea was reported in 1.8% of patients treated with prucalopride 2 mg compared to 1% of patients in the placebo group, and had a similar onset and duration as diarrhea overall.
Headache Of the patients who reported headache, 66% (157 out of 237) treated with prucalopride 2 mg once daily reported onset in the first 2 days of treatment.
Symptoms typically resolved within a few days in 65% (102 out of 157) of those patients.
Adverse Reactions Leading to Discontinuation In the 6 clinical trials described above, 5% of patients treated with 2 mg of prucalopride once daily discontinued due to adverse reactions, compared to 3% of patients in the placebo group.
The most common adverse reactions leading to discontinuation were nausea (2% prucalopride, 1% placebo), headache (1% prucalopride, 1% placebo), diarrhea (1% prucalopride, < 1% placebo), or abdominal pain (1% prucalopride, 1% placebo).
Adverse Reactions of Special Interest Adverse reactions of special interest were evaluated in a pool of 28 completed clinical trials (19 double-blind and 9 open-label) for prucalopride at doses including 0.5 mg, 1 mg, 2 mg, or 4 mg per day in adult patients with CIC (the recommended dosage of prucalopride for CIC is 2 mg once daily).
The total exposure in the double-blind trials was 565 patient-years in the prucalopride group, 384 patient-years in the placebo group, and 2,769 patient-years in the double-blind and open-label clinical trials.
Cardiovascular Safety Analysis In an evaluation by an independent adjudication committee of all potential major adverse cardiovascular events (MACE), defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, the standardized incidence rate (IR) per 1,000 patient-years for MACE for prucalopride was compared with the IR for placebo.
In the double-blind trials, the IR for MACE was 3.5 (2 patients out of 3,366; 1 patient on 2 mg and 1 patient on 4 mg) in the prucalopride group and 5.2 (2 patients out of 2,019) in the placebo group.
When combining the double-blind and open-label trials, the IR for MACE was 3.3 (9 patients out of 4,472, doses ranging between 0.5 mg to 4 mg) for prucalopride.
Suicidal Ideation and Behavior In the double-blind trials, one patient reported a suicide attempt 7 days after the end of treatment with prucalopride 2 mg once daily; none were reported in patients on placebo.
In the open-label trials, two patients reported a suicide attempt and another patient reported suicidal ideation.
Completed suicide was reported in two patients, previously treated with prucalopride 2 mg or 4 mg; both discontinued prucalopride for at least one month prior to the event.
Observational Cardiovascular Cohort Study The overall cardiovascular safety of prucalopride was assessed using European healthcare databases in a population-based, retrospective, observational, cohort study of
adults with constipation.
New users of prucalopride (N = 5,715) were matched to new users of polyethylene glycol 3350 (PEG) (N = 29,372) to estimate the standardized incidence rate ratio (SIRR) for MACE, pooled across four data sources.
The 95% confidence interval for the pooled estimate of the SIRR did not demonstrate an increased MACE risk and excluded a pre-specified safety margin of a three-fold risk of MACE during prucalopride use relative to PEG use.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of prucalopride.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity reactions :
Dyspnea, rash, pruritus, urticaria, and facial edema [see Contraindications (4) ] .
Psychiatric disorders:
Suicide, suicide attempts, suicidal ideation, self-injurious ideation, depression, anxiety, insomnia, nightmares, and visual hallucinations [see Warnings and Precautions (5.1) ].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling ( Patient Information ) Suicidal Ideation and Behavior :
Inform patients, their caregivers, and family members that suicidal ideation and behavior, self-injurious ideation as well as new onset or worsening depression have been reported in patients treated with prucalopride tablets.
Advise them to be aware of any unusual changes in mood or behavior, new onset or worsening of depression, or the emergence of suicidal thoughts or behavior.
Instruct patients, caregivers, and family members to discontinue prucalopride tablets immediately and contact their healthcare provider if any of these symptoms occur [see Warnings and Precautions (5.1) ] .
Pregnancy:
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to prucalopride during pregnancy [see Use in Specific Populations (8.1) ] .
Storage Advise patients to keep prucalopride tablets in the original container to protect from moisture.
Manufactured by:
Ritsa Pharma Private Limited Hyderabad, Telangana 500078, India (IND) Distributed by:
Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 For more information call 1-877-835-5472.
Rev. 11-2025-01

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Prucalopride Tablets:
1 mg prucalopride:
White to off-white, round, biconvex film-coated tablets debossed with “P1” on one side and plain on the other side. 2 mg prucalopride:
Yellow, round, biconvex film-coated tablets debossed with “P2” on one side and plain on the other side.
Tablets: 1 mg, 2 mg of prucalopride.
(3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Prucalopride tablets containing 1 mg prucalopride are white to off-white, round, biconvex film-coated tablets debossed with “P1” on one side and plain on other side.
They are supplied as:
NDC 69238-2698-1:
HDPE bottle of 30 tablets, with child-resistant closure.
Prucalopride tablets containing 2 mg prucalopride are yellow, round, biconvex film-coated tablets debossed with “P2” on one side and plain on other side.
They are supplied as:
NDC 69238-2699-1:
HDPE bottle of 30 tablets, with child-resistant closure.
Store prucalopride tablets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Store prucalopride tablets in the original container to protect from moisture.

Quoted from the official label, section “How Supplied”.

What is in it

Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT 4 ) receptor agonist.
The IUPAC name is:
4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate.
The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96 g/mol.
The structural formula is: Prucalopride succinate is a white to almost white powder.
It is sparingly soluble in dimethyl sulphoxide, methanol and soluble in water.
Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients:
anhydrous lactose, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose.
The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin.
Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients:
anhydrous lactose, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose.
The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide, and yellow iron oxide.
Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoseanhydrous lactoseMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (19)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 19 of 19

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (1)

FranceNo exact match for this strength and form

Every strength and form (2)

Details

Made by	Amneal Pharmaceuticals NY LLC
Active substance	Prucalopride
Strength	1 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 TABLET, FILM COATED in 1 BOTTLE
NDC	69238-2698

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

34 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated30 products
- 1 mg15
  1 mg · 15 companies
  - Alembic Pharmaceuticals Inc.
  - Alembic Pharmaceuticals Limited
  - Amneal Pharmaceuticals NY LLC · this page
  - Apotex Corp.
  - AvKARE
  - Camber Pharmaceuticals, Inc.
  - Cipla USA Inc.
  - Hikma Pharmaceuticals USA Inc
  +7 more
- 2 mg15
  2 mg · 15 companies
  +7 more
Tablet4 products
- 1 mg2
  1 mg · 2 companies
  - Ajanta Pharma USA Inc.
  - ANI Pharmaceuticals, Inc.
- 2 mg2
  2 mg · 2 companies
  - Ajanta Pharma USA Inc.
  - ANI Pharmaceuticals, Inc.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Motegrity1 mgPrescription onlyTablet, Film Coated Takeda Pharmaceuticals America, Inc. · Prucalopride Motegrity2 mgPrescription onlyTablet, Film Coated Takeda Pharmaceuticals America, Inc. · Prucalopride Prucalopride1 mgPrescription onlyTablet, Film Coated Hikma Pharmaceuticals USA Inc · Prucalopride Prucalopride2 mgPrescription onlyTablet, Film Coated Hikma Pharmaceuticals USA Inc · Prucalopride Prucalopride1 mgPrescription onlyTablet, Film Coated SpecGx LLC · Prucalopride Prucalopride2 mgPrescription onlyTablet, Film Coated SpecGx LLC · Prucalopride

See every product with Prucalopride