Home NDC 70518-4200 Prochlorperazine Maleate
Product NDC 70518-4200
11-digit product format 705184200
Labeler code 70518
Product ID 70518-4200_3ff4e764-1554-cca9-e063-6294a90accb7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Prochlorperazine Maleate
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA216495
Marketing category ANDA
Marketing start 2024-10-02
Substance PROCHLORPERAZINE MALEATE
Active strength 10 mg/1
Pharmacologic classes Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A216495-001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 A216495-002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08
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.
Product history page 1 of 2 · 56 observed 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 2026-08-18 06:07:40 2026-07 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216495-001 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 2022-08-08 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216495-002 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 2022-08-08 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Prochlorperazine Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROCHLORPERAZINE MALEATE 10 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 198365 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4200-0 Prochlorperazine Maleate 10 in 1 BOTTLE, PLASTIC TABLET 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4200 PROCHLORPERAZINE MALEATE TABLET [REMEDYREPACK INC.] 5 Current NDC, 1 package rows 20241213_5c1dd0ea-89e9-4317-a83e-5e15da79ca20.zip
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prochlorperazine Maleate PROCHLORPERAZINE MALEATE Northwind Health Company, LLC 115a4125-07df-9f9b-e063-6394a90a3e49 2026-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216495 application number: ANDA216495 Prochlorperazine Maleate PROCHLORPERAZINE MALEATE REMEDYREPACK INC. 5c1dd0ea-89e9-4317-a83e-5e15da79ca20 2025-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216495 application number: ANDA216495 ndc (product): 70518-4200 Prochlorperazine Maleate PROCHLORPERAZINE MALEATE Zydus Lifesciences Limited 1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c 2024-11-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216495 application number: ANDA216495 Prochlorperazine Maleate PROCHLORPERAZINE MALEATE Zydus Pharmaceuticals (USA) Inc. d4a34138-a01b-418f-8e0f-e81f6e1cfd89 2024-11-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216495 application number: ANDA216495
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4200-0 70518420000 10 TABLET in 1 BOTTLE, PLASTIC (70518-4200-0) 10 tablet 2024-10-02 No No Current