Prochlorperazine Maleate

Product NDC: 67296-0577
Requested package NDC: 67296-0577-1
11-digit product format: 672960577
Labeler code: 67296
Product ID: 67296-0577_9c9ae269-c660-4cd8-e053-2995a90ab98e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine Maleate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA040120
Marketing category: ANDA
Marketing start: 1996-07-25
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0577	67296-0577-1	I	Inactivated by FDA		2026-08-17

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 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`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
A040120-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-07-11
A040120-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-07-11

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A040120-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040120-002	AB	1	`ea99ee380514…`

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
67296-0577-1	2022-01-28	C162847	48780-1	d6a99b39-516b-a426-e053-dadaa90af4c2	4d9cd6b2-329f-539d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-0577-1	Prochlorperazine Maleate	15 in 1 BOTTLE	TABLET, FILM COATED	15		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0577	PROCHLORPERAZINE MALEATE TABLET, FILM COATED [REDPHARM DRUG, INC.]	4	Legacy NDC, 1 package rows	20200121_4d9cd6b2-329f-539d-e054-00144ff88e88.zip

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	4d9cd6b2-329f-539d-e054-00144ff88e88	4
312635	prochlorperazine 5 MG Oral Tablet	SCD	4d9cd6b2-329f-539d-e054-00144ff88e88	4
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	4d9cd6b2-329f-539d-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0577-1	67296057701	15 TABLET, FILM COATED in 1 BOTTLE (67296-0577-1)	1996-07-25	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.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	4