Home NDC 46708-077 PRUCALOPRIDE
Product NDC 46708-077
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219234-001 PRUCALOPRIDE SUCCINATE PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2026-07-27 A219234-002 PRUCALOPRIDE SUCCINATE PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2026-07-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219234-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2026-07-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219234-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2026-07-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219234-001 PRUCALOPRIDE SUCCINATE EQ 1MG BASE TABLET / ORAL AB 2026-07-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219234-002 PRUCALOPRIDE SUCCINATE EQ 2MG BASE TABLET / ORAL AB 2026-07-27 caaa826d4ba7…
Observed Orange Book normalized TE history# 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 Ingredient Strength PRUCALOPRIDE SUCCINATE 1 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2107345 Internal RxNorm lookup 2107353 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 46708-077-30 46708007730 30 TABLET, FILM COATED in 1 BOTTLE (46708-077-30) 2026-07-31 No No Current