PROCHLORPERAZINE MALEATE

Product NDC: 67296-2178
11-digit product format: 672962178
Labeler code: 67296
Product ID: 67296-2178_44f66722-751c-1a63-e063-6294a90ad3c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA217478
Marketing category: ANDA
Marketing start: 2025-01-31
Substance: PROCHLORPERAZINE MALEATE
Active strength: 5 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
A217478-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		2023-04-04
A217478-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB		2023-04-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217478-001	AB
A217478-002	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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2023-04-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2023-04-04	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217478-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217478-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217478-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217478-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217478-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217478-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217478-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217478-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217478-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217478-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217478-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217478-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217478-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217478-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217478-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217478-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217478-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217478-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217478-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217478-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217478-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217478-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217478-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217478-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A217478-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217478-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217478-002	AB	1	`9b2671bbb829…`

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	5 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
312635	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3dd03606-1f58-43ac-e063-6294a90a4439	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-2178-1	PROCHLORPERAZINE MALEATE	15 in 1 BOTTLE	TABLET	15		2

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	44f278eb-3588-af83-e063-6394a90a73cf	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	f387b07a-2d99-4fd5-bcd1-8f04e69b8a39	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	3dd03606-1f58-43ac-e063-6294a90a4439	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478 ndc (product): 67296-2178
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	c622550a-4f61-47f7-bc6b-9545d5d4e031	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Preferred Pharmaceuticals Inc.	f3adc8a4-2c2b-4d5e-803f-38361966cc68	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	a826f111-4186-47d3-99c1-a72d75776c4c	2025-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	18988af8-545a-3b69-e063-6394a90ae074	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bionpharma Inc.	052d351a-978b-6fc3-e063-6294a90aef55	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bionpharma Inc.	2cf363d6-b9e4-2c22-e063-6394a90a7649	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	86102abe-0b72-4352-95ce-db88d2e14002	2024-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217478 application number: ANDA217478

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	3dd03606-1f58-43ac-e063-6294a90a4439	2
312635	prochlorperazine 5 MG Oral Tablet	SCD	3dd03606-1f58-43ac-e063-6294a90a4439	2
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	3dd03606-1f58-43ac-e063-6294a90a4439	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2178-1	67296217801	15 TABLET in 1 BOTTLE (67296-2178-1)	15 tablet	2025-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prochlorperazine Maleate Tablets, USP Rx Only	Redpharm Drug	2025-12-02	HUMAN PRESCRIPTION DRUG LABEL	2