FDA.reportPublic FDA data

CISAPRIDE MONOHYDRATE USP

Manufacturer
LETCO MEDICAL, LLC
Effective date
2026-08-19
Label type
BULK INGREDIENT - ANIMAL DRUG
Version
5
Source
daily-update
Hydrated at
2026-08-21 02:02:30

Label at a glance#

ProductCISAPRIDE MONOHYDRATE
Active ingredientCISAPRIDE MONOHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cisapride Monohydrate USP 100g
Cisapride Monohydrate USP 100g

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00362991319135(10)000000000(17)280730GTIN-14: 00362991319135
GTIN-12: 362991319135
UPC-A: 362991319135
EAN-13: 0362991319135
GTIN storage (14 digits): 00362991319135		cisapride-monohydrate-usp-1.jpg

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62991-3191-1GM - Gram62991-319190ac9b99-cc3a-4421-8ef3-39c5653d207112023-10-16
62991-3191-2GM - Gram62991-319117e67ec6-e063-47db-8df1-4defc2edbb4c12023-10-16
62991-3191-3GM - Gram62991-31911b6fb369-142f-458f-badf-f0591e27bb4212023-10-16
62991-3191-4GM - Gram62991-3191243c2efa-281b-497a-989a-b7684dc8e9f112023-10-16

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
62991-319162991-3191-1, 62991-3191-2, 62991-3191-3, 62991-3191-4

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-06-19monthly-update2026-07-17 21:37:28
32024-07-18full-release2026-06-01 02:51:49

Reported adverse events (FAERS/openFDA)#

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