Prucalopride Tablets, For Oral Use

SPL v1

SPL

SPL Set ID da37395d-0a05-4fdc-ab5c-eb7caed62bf1

Route

ORAL

Published

Effective Date 2026-01-30

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Prucalopride (1 mg)

Inactive Ingredients

Hypromellose 2910 (3 Mpa.s) Magnesium Stearate Microcrystalline Cellulose 101 Polyethylene Glycol, Unspecified Silicon Dioxide Starch, Corn Titanium Dioxide Triacetin Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance

Imprint: 1754 Shape: round Color: white Color: yellow Size: 6 mm Size: 9 mm Score: 1

Marketing Status

ANDA Active Since 2026-02-02

Description

NDC 70771-1899-3 Prucalopride Tablets 1 mg tablet 30 Tablets Rx only NDC 70771-1900-3 Prucalopride Tablets 2 mg tablet 30 Tablets Rx only

Medication Information

Description

NDC 70771-1899-3 Prucalopride Tablets 1 mg tablet 30 Tablets Rx only NDC 70771-1900-3 Prucalopride Tablets 2 mg tablet 30 Tablets Rx only

Package Label.principal Display Panel

NDC 70771-1899-3

Prucalopride Tablets

1 mg tablet

30 Tablets

Rx only

NDC 70771-1900-3

Prucalopride Tablets

2 mg tablet

30 Tablets

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1899-3

Prucalopride Tablets

1 mg tablet

30 Tablets

Rx only

NDC 70771-1900-3

Prucalopride Tablets

2 mg tablet

30 Tablets

Rx only

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1899-3 Prucalopride Tablets 1 mg tablet 30 Tablets Rx only NDC 70771-1900-3 Prucalopride Tablets 2 mg tablet 30 Tablets Rx only"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:53:02.972400 · Updated: 2026-03-14T22:45:20.597363