PROCHLORPERAZINE MALEATE

Product NDC: 67296-0727
11-digit product format: 672960727
Labeler code: 67296
Product ID: 67296-0727_d60cd787-bd9b-720b-e053-2a95a90a54b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROCHLORPERAZINE MALEATE
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA040268
Marketing category: ANDA
Marketing start: 1998-03-01
Marketing end: 0000-00-00
Substance: PROCHLORPERAZINE MALEATE
Active strength: 5 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-0727		I	Inactivated by FDA		2026-08-07
excluded package	package	67296-0727	67296-0727-1	I	Inactivated by FDA		2026-08-07

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 · 34 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-0727-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-0727-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-0727-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-0727-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-0727-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-0727-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-0727-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-0727-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-0727-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-0727-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-0727-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-0727-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0727-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0727-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0727-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67296-0727-1	E	Excluded after deficient or non-compliant submission was not corrected	`fb8cb913e6d1…`	`eb8c232b6be0…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-0727-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040268-001	PROCOMP	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27
A040268-002	PROCOMP	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040268-001	AB
A040268-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB		1998-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040268-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040268-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040268-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040268-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040268-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040268-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040268-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040268-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040268-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040268-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040268-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040268-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9bfe4595-32b8-9175-3af8-875e9c4c0538	Product name	6	20260305
7335ddeb-6cbd-135c-487d-96fa4587ad65	Product name	6	20250331
a6ffe0a0-7823-b305-75e9-2a5c6f2be4ac	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-0727-1	2024-01-30	C162847	48780-1	1030e365-682c-111a-e063-dadaa90a10e2	4175d760-a84d-0b7f-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0727-1	PROCHLORPERAZINE MALEATE	15 in 1 BOTTLE	TABLET	15		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0727	PROCHLORPERAZINE MALEATE TABLET [REDPHARM DRUG, INC.]	5	Legacy NDC, 1 package rows	20220121_4175d760-a84d-0b7f-e054-00144ff88e88.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Sportpharm LLC	3d28dab2-0264-482e-b99d-f56a9314b8a5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	fc77a504-4642-47c1-b2e3-c5db11e5816d	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	8b58b63c-0a75-406b-bb29-acf0a40353bd	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	f2f12ccc-6e51-0a67-e053-2995a90a22bc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	QPharma, Inc.	dc692e77-5240-4aa6-8fe9-9ffcbb267261	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Jubilant Cadista Pharmaceuticals Inc.	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Cardinal Health 107, LLC	45f56f93-50a7-4cd3-bce2-f97a80556651	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	AvPAK	86ac7223-b840-bc0c-e053-2991aa0a32f2	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Direct_Rx	02069e43-5245-20dc-e063-6294a90a9dcd	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	664da979-a480-4482-a5a5-0ec98d4c0037	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	NuCare Pharmaceuticals, Inc.	40bd3a0c-368f-64e9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Proficient Rx LP	565e4b1b-04be-47b4-99b0-903fc2ed47af	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	383744db-ba57-478a-8041-2ecc26d3e1ec	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I1T8O1JTL6	PROCHLORPERAZINE MALEATE	84-02-6	PROCHLORPERAZINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	4175d760-a84d-0b7f-e054-00144ff88e88	5
312635	prochlorperazine 5 MG Oral Tablet	SCD	4175d760-a84d-0b7f-e054-00144ff88e88	5
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	4175d760-a84d-0b7f-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0727-1	67296072701	15 TABLET in 1 BOTTLE (67296-0727-1)	15 tablet	1998-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCHLORPERAZINE MALEATE - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	5