FDA.reportPublic FDA data

prucalopride

Product NDC
70771-1900
11-digit product format
707711900
Labeler code
70771
Product ID
70771-1900_051f4f7e-88e8-4706-8183-dbd3f9d42d72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prucalopride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA218056
Marketing category
ANDA
Marketing start
2026-02-02
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
2027-12-31
Current FDA listing
Yes

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
70771-1900-3prucalopride30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107345prucalopride 1 MG Oral TabletPSNda37395d-0a05-4fdc-ab5c-eb7caed62bf11
2107353prucalopride 2 MG Oral TabletPSNda37395d-0a05-4fdc-ab5c-eb7caed62bf11
2107345prucalopride 1 MG Oral TabletSCDda37395d-0a05-4fdc-ab5c-eb7caed62bf11
2107353prucalopride 2 MG Oral TabletSCDda37395d-0a05-4fdc-ab5c-eb7caed62bf11
2107345prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral TabletSYda37395d-0a05-4fdc-ab5c-eb7caed62bf11
2107353prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral TabletSYda37395d-0a05-4fdc-ab5c-eb7caed62bf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1900-37077119000330 TABLET, FILM COATED in 1 BOTTLE (70771-1900-3) 2026-02-02NoNoHistorical