Home NDC 0615-2519 Prochlorperazine Maleate
Product NDC 0615-2519
11-digit product format 006152519
Labeler code 0615
Product ID 0615-2519_d7adb695-e703-4ec9-8517-b759d3bd3cf0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prochlorperazine maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA040185
Marketing category ANDA
Marketing start 2010-12-13
Marketing end 0000-00-00
Substance PROCHLORPERAZINE MALEATE
Active strength 5 mg/1
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-2519-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-2519-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-2519-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-2519-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-2519-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-2519-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-2519-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-2519-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-2519-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-2519-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-2519-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-2519-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-2519-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-2519-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-2519-39 I Inactivated by FDA 110d247fa046…a55b01930146…
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 A040185-001 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 A040185-002 PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28
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 3 · 84 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 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL 1996-10-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL 1996-10-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 1996-10-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 1996-10-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 1996-10-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 1996-10-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 1996-10-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 1996-10-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 1996-10-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 1996-10-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040185-001 PROCHLORPERAZINE MALEATE EQ 10MG BASE TABLET / ORAL AB 1996-10-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040185-002 PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET / ORAL AB 1996-10-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROCHLORPERAZINE MALEATE ACTIVE INGREDIENT I1T8O1JTL6 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 PROCHLORPERAZINE ACTIVE MOIETY YHP6YLT61T PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8