Quick answers
- What is Prucalopride used for?
- The FDA-approved label (Motegrity, Takeda Pharmaceuticals America, Inc., July 17, 2025) says: “MOTEGRITY ® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. MOTEGRITY is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Prucalopride have a boxed warning?
- No. None of the 17 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Prucalopride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Prucalopride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Prucalopride?
- 19 companies list prescription products of Prucalopride in the FDA NDC Directory, including Viona Pharmaceuticals Inc, AvKARE and ANI Pharmaceuticals, Inc..
What Prucalopride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
MOTEGRITY ® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. MOTEGRITY is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
— FDA label: Motegrity, Takeda Pharmaceuticals America, Inc., effective July 17, 2025. Read the full label on DailyMed →
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 38 in the FDA NDC Directory |
| Brand names | Motegrity |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| prucalopride 1 mg tablet | Generic | $0.6336 per tablet |
| prucalopride 1 mg tablet, film coated | Generic | $0.6336 per tablet |
| prucalopride 2 mg tablet | Generic | $0.6154 per tablet |
| prucalopride 2 mg tablet, film coated | Generic | $0.6154 per tablet |
| prucalopride succinate 1 mg tablet | Generic | $0.6336 per tablet |
| prucalopride succinate 1 mg tablet, film coated | Generic | $0.6336 per tablet |
| prucalopride succinate 1 mg tablet, film coated | Brand: Motegrity | $17.72 per tablet |
| prucalopride succinate 2 mg tablet | Generic | $0.6154 per tablet |
| prucalopride succinate 2 mg tablet, film coated | Generic | $0.6154 per tablet |
| prucalopride succinate 2 mg tablet, film coated | Brand: Motegrity | $17.75 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Viona Pharmaceuticals Inc2 products
- AvKARE2 products
- ANI Pharmaceuticals, Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Takeda Pharmaceuticals America, Inc.2 products
- Novadoz Pharmaceuticals LLC2 products
- Alembic Pharmaceuticals Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Zydus Lifesciences Limited2 products
- SKG Pharma Inc.2 products
- Somerset Therapeutics, LLC2 products
- Cipla USA Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- Hikma Pharmaceuticals USA Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- Apotex Corp.2 products
- Sandoz Inc2 products
- SpecGx LLC2 products
- Ajanta Pharma USA Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210166 MOTEGRITY | Takeda Pharms USA | December 14, 2018 | 2, latest July 10, 2025 2025: Efficacy · 2020: Labeling |
Generic approvals (14)
- ANDA218492Novitium Pharma · December 26, 2024
- ANDA217662Hikma · June 24, 2025
- ANDA218177Msn · June 24, 2025
- ANDA218795Zenara · June 24, 2025
- ANDA218812Amneal · June 24, 2025
- ANDA218847Lupin · June 24, 2025
- ANDA218963Appco · June 24, 2025
- ANDA218977Apotex · June 24, 2025
- ANDA219078Somerset Therap · June 24, 2025
- ANDA219160Annora Pharma · June 24, 2025
- ANDA219193Specgx LLC · June 24, 2025
- ANDA218056Zydus Lifesciences · August 7, 2025
- ANDA219220Ajanta Pharma Ltd · January 16, 2026
- ANDA219234Alembic · July 27, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2107345, 2107351, 2107353, 2107355 |
|---|---|
| SPL set ID of the quoted label | bca1e4c6-4b2b-4876-8ab3-654629c4ff1b |
| FDA labels (SPL) | 17 |
| FDA applications | NDA210166, 14 ANDA |
| Active ingredients (FDA) | PRUCALOPRIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Motegrity, Takeda Pharmaceuticals America, Inc., effective July 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →