FDA.reportPublic FDA data

PRUCALOPRIDE

Product NDC
46708-077
Requested package NDC
46708-077-30
11-digit product format
467080077
Labeler code
46708
Product ID
46708-077_89a7bdb1-e1cd-4986-bab9-a939dc764faa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRUCALOPRIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA219234
Marketing category
ANDA
Marketing start
2026-07-31
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219234-001PRUCALOPRIDE SUCCINATEPRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2026-07-27
A219234-002PRUCALOPRIDE SUCCINATEPRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2026-07-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219234-001AB
A219234-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219234-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2026-07-2784e616aacf4f…
2026-09-14 22:38:342026-08A219234-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2026-07-2784e616aacf4f…
2026-08-18 06:07:402026-07A219234-001PRUCALOPRIDE SUCCINATEEQ 1MG BASETABLET / ORALAB2026-07-27caaa826d4ba7…
2026-08-18 06:07:402026-07A219234-002PRUCALOPRIDE SUCCINATEEQ 2MG BASETABLET / ORALAB2026-07-27caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219234-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219234-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A219234-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219234-002AB1caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4V2G75E1CKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2107345Internal RxNorm lookup
2107353Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89a7bdb1-e1cd-4986-bab9-a939dc764faaAvailable 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRUCALOPRIDEPRUCALOPRIDEAlembic Pharmaceuticals Limited89a7bdb1-e1cd-4986-bab9-a939dc764faa2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219234
application number: ANDA219234
ndc (package): 46708-077-30
ndc (product): 46708-077
ndc11 (package): 46708007730
PRUCALOPRIDEPRUCALOPRIDEAlembic Pharmaceuticals Inc.a537fb70-eb4e-4498-aaef-9944ff3900092026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219234
application number: ANDA219234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46708-077-304670800773030 TABLET, FILM COATED in 1 BOTTLE (46708-077-30) 2026-07-31NoNoCurrent