FDA.reportPublic FDA data

MOTEGRITY

Product NDC
54092-546
11-digit product format
540920546
Labeler code
54092
Product ID
54092-546_1278ace1-66f8-4bd8-8cf0-bd731f936563
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRUCALOPRIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA210166
Marketing category
NDA
Marketing start
2018-12-14
Substance
PRUCALOPRIDE SUCCINATE
Active strength
1 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
MOTEGRITY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRUCALOPRIDE SUCCINATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4V2G75E1CK
Rxcui2107345, 2107351, 2107353, 2107355

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
54092-546-01MOTEGRITY30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-546-01EA - Each54092-546f141b529-b3c6-4a19-94b4-6977c8ddf73612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-546MOTEGRITY (PRUCALOPRIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]11Current NDC, Legacy NDC, 1 package rows20250311_bca1e4c6-4b2b-4876-8ab3-654629c4ff1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107351motegrity 1 MG Oral TabletPSNbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107355motegrity 2 MG Oral TabletPSNbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107345prucalopride 1 MG Oral TabletPSNbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107353prucalopride 2 MG Oral TabletPSNbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107351prucalopride 1 MG Oral Tablet [Motegrity]SBDbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107355prucalopride 2 MG Oral Tablet [Motegrity]SBDbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107345prucalopride 1 MG Oral TabletSCDbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107353prucalopride 2 MG Oral TabletSCDbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107351Motegrity 1 MG Oral TabletSYbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107355Motegrity 2 MG Oral TabletSYbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107345prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral TabletSYbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12
2107353prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral TabletSYbca1e4c6-4b2b-4876-8ab3-654629c4ff1b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54092-546-015409205460130 TABLET, FILM COATED in 1 BOTTLE (54092-546-01) 2018-12-140000-00-00NoNoCurrent