Home NDC 70518-4728 prochlorperazine maleate
Product NDC 70518-4728
11-digit product format 705184728
Labeler code 70518
Product ID 70518-4728_5965d9e3-b649-4050-e063-6294a90abea5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prochlorperazine maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA218734
Marketing category ANDA
Marketing start 2026-08-19
Substance PROCHLORPERAZINE MALEATE
Active strength 5 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
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 A218734-001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2025-09-08 A218734-002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2025-09-08
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 A218734-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2025-09-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218734-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2025-09-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218734-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2025-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218734-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2025-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218734-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2025-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218734-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2025-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218734-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2025-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218734-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2025-09-08 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218734-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2025-09-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218734-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2025-09-08 a50c72e98297…
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 prochlorperazine maleate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROCHLORPERAZINE MALEATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination I1T8O1JTL6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312635 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 70518-4728-0 70518472800 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4728-0) 2026-08-19 No No Current