PROCHLORPERAZINE MALEATE

Product NDC: 69315-265
11-digit product format: 693150265
Labeler code: 69315
Product ID: 69315-265_e9585ce8-2433-4d85-ab3a-c544d7cb1532
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROCHLORPERAZINE MALEATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Leading Pharma, LLC
Application: ANDA218912
Marketing category: ANDA
Marketing start: 2025-06-25
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
A218912-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		2024-09-30
A218912-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB		2024-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218912-001	AB
A218912-002	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.

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	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218912-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2024-09-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218912-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2024-09-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A218912-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218912-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218912-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218912-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218912-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218912-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218912-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218912-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218912-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218912-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218912-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218912-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218912-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218912-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218912-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218912-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218912-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218912-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218912-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218912-002	AB	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218912-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218912-002	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198365	Internal RxNorm lookup
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
c93494ef-c510-4e46-a1b1-362624200223	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
69315-265-01	PROCHLORPERAZINE MALEATE	100 in 1 BOTTLE	TABLET, FILM COATED	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69315-265-01	EA - Each	69315-265	697a65b1-4a7b-4369-9e24-974bf00675eb	1	2025-08-11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	3b022837-0fcc-d38a-e063-6394a90a0f7f	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218912 application number: ANDA218912
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Leading Pharma, LLC	c93494ef-c510-4e46-a1b1-362624200223	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218912 application number: ANDA218912 ndc (product): 69315-265

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
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	3b022837-0fcc-d38a-e063-6394a90a0f7f	5
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	3b022837-0fcc-d38a-e063-6394a90a0f7f	5
198365	prochlorperazine 10 MG Oral Tablet	SCD	3b022837-0fcc-d38a-e063-6394a90a0f7f	5
312635	prochlorperazine 5 MG Oral Tablet	SCD	3b022837-0fcc-d38a-e063-6394a90a0f7f	5
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	3b022837-0fcc-d38a-e063-6394a90a0f7f	5
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	3b022837-0fcc-d38a-e063-6394a90a0f7f	5
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	c93494ef-c510-4e46-a1b1-362624200223	2
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	c93494ef-c510-4e46-a1b1-362624200223	2
198365	prochlorperazine 10 MG Oral Tablet	SCD	c93494ef-c510-4e46-a1b1-362624200223	2
312635	prochlorperazine 5 MG Oral Tablet	SCD	c93494ef-c510-4e46-a1b1-362624200223	2
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	c93494ef-c510-4e46-a1b1-362624200223	2
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	c93494ef-c510-4e46-a1b1-362624200223	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69315-265-01	69315026501	100 TABLET, FILM COATED in 1 BOTTLE (69315-265-01)	2025-06-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prochlorperazine Maleate Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	5
Prochlorperazine Maleate Tablets, USP Rx only	Leading Pharma, LLC	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL	2