Prochlorperazine Maleate

Product NDC: 67296-2342
Requested package NDC: 67296-2342-4
11-digit product format: 672962342
Labeler code: 67296
Product ID: 67296-2342_5d769974-1435-907d-e063-6394a90ac3af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA216202
Marketing category: ANDA
Marketing start: 2023-09-07
Substance: PROCHLORPERAZINE MALEATE
Active strength: 10 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A216202-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		2022-06-13
A216202-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB		2022-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216202-001	AB
A216202-002	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 · 60 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
2026-09-14 22:38:34	2026-08	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216202-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-06-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216202-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-06-13	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216202-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216202-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216202-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216202-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216202-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216202-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216202-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216202-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216202-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216202-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216202-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216202-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216202-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216202-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216202-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216202-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216202-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216202-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216202-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216202-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216202-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216202-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216202-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216202-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216202-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216202-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216202-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216202-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216202-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216202-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216202-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216202-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216202-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216202-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216202-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216202-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216202-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216202-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216202-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216202-002	AB	1	`a72a2bbeb626…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Major Pharmaceuticals	d6fc83ad-9cce-4e60-854c-3825313ee60c	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216202 application number: ANDA216202
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	ANI Pharmaceuticals, Inc.	50ce4381-94ef-49ff-8794-cfde0ee803b4	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216202 application number: ANDA216202
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Northstar Rx LLC	04bf8a16-218a-c648-e063-6294a90a1afb	2025-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216202 application number: ANDA216202

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2342-4	67296234204	15 TABLET in 1 BOTTLE (67296-2342-4)	15 tablet	2023-09-07	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCHLORPERAZINE MALEATE TABLETS, USP Rx only	Redpharm Drug	2026-10-10	HUMAN PRESCRIPTION DRUG LABEL	1