FDA.reportPublic FDA data

Cisapride Monohydrate

Manufacturer
H3 Medical Inc.
Effective date
2019-01-16
Label type
BULK INGREDIENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:12

Label at a glance#

ProductCisapride Monohydrate
Active ingredientCISAPRIDE MONOHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cisapride MonohydrateCisapride Monohydrate

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
63732-2006-1Cisapride Monohydrate4000 g in 1 PAILPOWDER40002
63732-2006-3Cisapride Monohydrate50 g in 1 BOTTLEPOWDER502
63732-2006-4Cisapride Monohydrate100 g in 1 BOTTLEPOWDER1002
63732-2006-5Cisapride Monohydrate500 g in 1 BOTTLEPOWDER5002
63732-2006-6Cisapride Monohydrate1000 g in 1 BOTTLEPOWDER10002
63732-2006-7Cisapride Monohydrate5000 g in 1 CONTAINERPOWDER50002
63732-2006-8Cisapride Monohydrate10000 g in 1 CONTAINERPOWDER100002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63732-2006CISAPRIDE MONOHYDRATE POWDER [H3 MEDICAL INC.]27 package rows20190117_9ea55f9b-d3b9-4441-b9ae-cb78934ef099.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CISAPRIDE MONOHYDRATEACTIVE INGREDIENTVZV0A4I38W1
CISAPRIDEACTIVE MOIETYUVL329170W1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63732-200663732-2006-3, 63732-2006-4, 63732-2006-5, 63732-2006-6, 63732-2006-7, 63732-2006-8, 63732-2006-1

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.