Home NDC 55289-224 Prochlorperazine Maleate
Product NDC 55289-224
11-digit product format 552890224
Labeler code 55289
Product ID 55289-224_d2453993-3e0f-27e1-e053-2a95a90afce9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name prochlorperazine maleate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA040185
Marketing category ANDA
Marketing start 1996-11-18
Marketing end 0000-00-00
Substance PROCHLORPERAZINE MALEATE
Active strength 10 mg/1
Pharmacologic classes Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# 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 [PD-RX PHARMACEUTICALS, INC.] 3 PROCHLORPERAZINE ACTIVE MOIETY YHP6YLT61T PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-224-04 55289022404 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-224-04) 2010-12-30 0000-00-00 No No Current 55289-224-12 55289022412 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-224-12) 2010-12-30 0000-00-00 No No Current 55289-224-15 55289022415 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-224-15) 2010-12-30 0000-00-00 No No Current 55289-224-20 55289022420 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-224-20) 2010-12-30 0000-00-00 No No Current