FDA.reportPublic FDA data

Cisapride Monohydrate

Manufacturer
Fagron Inc
Effective date
2023-10-30
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
8
Source
full-release
Hydrated at
2026-06-01 02:50:54

Label at a glance#

ProductCisapride Monohydrate
Active ingredientCISAPRIDE MONOHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cisapride Monohydrate 1 kgCisapride Monohydrate 1 kg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4e2baf7-73e6-4103-93f8-b19723717eafProduct name120201013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51552-0896-3Cisapride Monohydrate5 g in 1 CONTAINERPOWDER58
51552-0896-4Cisapride Monohydrate25 g in 1 CONTAINERPOWDER258
51552-0896-5Cisapride Monohydrate100 g in 1 CONTAINERPOWDER1008
51552-0896-7Cisapride Monohydrate1000 g in 1 CONTAINERPOWDER10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51552-0896CISAPRIDE MONOHYDRATE POWDER [FAGRON INC]84 package rows20231031_91946539-e952-4998-857b-fb5f728e1923.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51552-089651552-0896-3, 51552-0896-4, 51552-0896-5, 51552-0896-7

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CISAPRIDE MONOHYDRATEVZV0A4I38WACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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