FDA.reportPublic FDA data

PRUCALOPRIDE tablets, for oral use

Manufacturer
Zydus Lifesciences Limited
Effective date
2026-01-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:58:37

Label at a glance#

Productprucalopride
Active ingredientPRUCALOPRIDE SUCCINATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1899-3

Prucalopride Tablets

1 mg tablet

30 Tablets

Rx only

1 mg label
1 mg label

NDC 70771-1900-3

Prucalopride Tablets

2 mg tablet

30 Tablets

Rx only

2 mg label
2 mg label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2107345prucalopride 1 MG Oral TabletPSN1
2107353prucalopride 2 MG Oral TabletPSN1
2107345prucalopride 1 MG Oral TabletSCD1
2107353prucalopride 2 MG Oral TabletSCD1
2107345prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral TabletSY1
2107353prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PRUCALOPRIDE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20210415

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c75476a7-e531-4d47-9c48-19159bd43a92Product name220251024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1899-3prucalopride30 in 1 BOTTLETABLET, FILM COATED301
70771-1900-3prucalopride30 in 1 BOTTLETABLET, FILM COATED301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-189970771-1899-3
70771-190070771-1900-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
PRUCALOPRIDE SUCCINATE4V2G75E1CKACTIM
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
PRUCALOPRIDE SUCCINATE4V2G75E1CKACTIM
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSE 1017T9FYH5QMKIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218056-001PRUCALOPRIDE SUCCINATEPRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2025-08-07
A218056-002PRUCALOPRIDE SUCCINATEPRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2025-08-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218056-001AB
A218056-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218056-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2025-08-0784e616aacf4f…
2026-09-14 22:38:342026-08A218056-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2025-08-0784e616aacf4f…
2026-08-18 06:07:402026-07A218056-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2025-08-07caaa826d4ba7…
2026-08-18 06:07:402026-07A218056-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2025-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218056-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2025-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218056-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2025-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218056-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2025-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218056-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2025-08-0731067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218056-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2025-08-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218056-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2025-08-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218056-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218056-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A218056-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218056-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218056-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218056-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218056-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218056-002AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prucalopridePRUCALOPRIDEZydus Lifesciences Limitedda37395d-0a05-4fdc-ab5c-eb7caed62bf12026-01-30Exact identifier
ndc (package): 70771-1899-3
ndc (package): 70771-1900-3
ndc (product): 70771-1900
ndc (product): 70771-1899
ndc11 (package): 70771189903
ndc11 (package): 70771190003
spl id: 051f4f7e-88e8-4706-8183-dbd3f9d42d72
spl set id: da37395d-0a05-4fdc-ab5c-eb7caed62bf1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.