FDA.reportPublic FDA data

PRUCALOPRIDE

Product NDC
72205-218
11-digit product format
722050218
Labeler code
72205
Product ID
72205-218_89a7fce6-5d3e-4a71-a86c-06d209951c63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRUCALOPRIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA218177
Marketing category
ANDA
Marketing start
2025-06-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRUCALOPRIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRUCALOPRIDE SUCCINATE1 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-218-30PRUCALOPRIDE30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-218-30EA - Each72205-218ebc92d12-5c59-4c8a-b0e8-d24da71d6f6512025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2107345prucalopride 1 MG Oral TabletPSN1f195f1d-d509-4f8b-8710-2d0d110b6b5c3
2107353prucalopride 2 MG Oral TabletPSN1f195f1d-d509-4f8b-8710-2d0d110b6b5c3
2107345prucalopride 1 MG Oral TabletSCD1f195f1d-d509-4f8b-8710-2d0d110b6b5c3
2107353prucalopride 2 MG Oral TabletSCD1f195f1d-d509-4f8b-8710-2d0d110b6b5c3
2107345prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral TabletSY1f195f1d-d509-4f8b-8710-2d0d110b6b5c3
2107353prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral TabletSY1f195f1d-d509-4f8b-8710-2d0d110b6b5c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72205-218-307220502183030 TABLET, FILM COATED in 1 BOTTLE (72205-218-30) 2025-06-24NoNoCurrent