PRUCALOPRIDE

Product NDC: 62332-078
11-digit product format: 623320078
Labeler code: 62332
Product ID: 62332-078_b1c03c28-cd41-4ef2-a79e-f1912cb75d9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PRUCALOPRIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA219234
Marketing category: ANDA
Marketing start: 2026-07-31
Substance: PRUCALOPRIDE SUCCINATE
Active strength: 2 mg/1
Pharmacologic classes: Serotonin 4 Receptor Agonists [MoA]; Serotonin-4 Receptor Agonist [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PRUCALOPRIDE SUCCINATE	2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4V2G75E1CK	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a537fb70-eb4e-4498-aaef-9944ff390009	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRUCALOPRIDE	PRUCALOPRIDE	Alembic Pharmaceuticals Limited	89a7bdb1-e1cd-4986-bab9-a939dc764faa	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219234 application number: ANDA219234
PRUCALOPRIDE	PRUCALOPRIDE	Alembic Pharmaceuticals Inc.	a537fb70-eb4e-4498-aaef-9944ff390009	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219234 application number: ANDA219234 ndc (product): 62332-078

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4V2G75E1CK	PRUCALOPRIDE SUCCINATE	179474-85-2	PRUCALOPRIDE SUCCINATE
0A09IUW5TP	PRUCALOPRIDE	179474-81-8	PRUCALOPRIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Status
62332-078-30	62332007830	30 TABLET, FILM COATED in 1 BOTTLE (62332-078-30)	2026-07-31	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PRUCALOPRIDE	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited (Formulation Division-IV)	2026-07-31	Human Prescription Drug Label	4