Prucalopride

Product NDC
73190-039
11-digit product format
731900039
Labeler code
73190
Product ID
73190-039_3ac28f12-c01a-6725-e063-6294a90a663a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prucalopride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA218977
Marketing category
ANDA
Marketing start
2025-07-25
Substance
PRUCALOPRIDE SUCCINATE
Active strength
2 mg/1
Pharmacologic classes
Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prucalopride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRUCALOPRIDE SUCCINATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4V2G75E1CK
Rxcui2107345, 2107353

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
73190-039-30Prucalopride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-039-30EA - Each73190-039792a9df4-20da-4dee-a631-0ab1ee3a158712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107345prucalopride 1 MG Oral TabletPSN3ac293af-5ce2-33f1-e063-6394a90aa01f1
2107353prucalopride 2 MG Oral TabletPSN3ac293af-5ce2-33f1-e063-6394a90aa01f1
2107345prucalopride 1 MG Oral TabletSCD3ac293af-5ce2-33f1-e063-6394a90aa01f1
2107353prucalopride 2 MG Oral TabletSCD3ac293af-5ce2-33f1-e063-6394a90aa01f1
2107345prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral TabletSY3ac293af-5ce2-33f1-e063-6394a90aa01f1
2107353prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral TabletSY3ac293af-5ce2-33f1-e063-6394a90aa01f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-039-307319000393030 TABLET, FILM COATED in 1 BOTTLE (73190-039-30) 2025-07-25NoNoHistorical