Application 040120

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	TABLET;ORAL	EQ 5MG BASE	No	No
002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	TABLET;ORAL	EQ 10MG BASE	No	No

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
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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040120-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	1996-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040120-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	1996-07-11	`84e616aacf4f…`
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…`

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…`

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Cardinal Health 107, LLC	45f56f93-50a7-4cd3-bce2-f97a80556651	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	f387b07a-2d99-4fd5-bcd1-8f04e69b8a39	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	3dd03606-1f58-43ac-e063-6294a90a4439	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Ajanta Pharma USA Inc.	9ab78746-b302-4836-95f3-343799929c0e	2025-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	AvPAK	86ac7223-b840-bc0c-e053-2991aa0a32f2	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
prochlorperazine maleate	PROCHLORPERAZINE MALEATE	Aurobindo Pharma Limited	7ec4df20-9ea5-4a68-a43f-5ded4eaed235	2025-09-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: prochlorperazine maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Leading Pharma, LLC	c93494ef-c510-4e46-a1b1-362624200223	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	a826f111-4186-47d3-99c1-a72d75776c4c	2025-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Redpharm Drug	18988af8-545a-3b69-e063-6394a90ae074	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	3ccd11d3-5e5e-4ed8-9b0c-49b0a84535ab	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bionpharma Inc.	052d351a-978b-6fc3-e063-6294a90aef55	2025-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Northstar Rx LLC	04bf8a16-218a-c648-e063-6294a90a1afb	2025-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bionpharma Inc.	2cf363d6-b9e4-2c22-e063-6394a90a7649	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Direct_Rx	02069e43-5245-20dc-e063-6294a90a9dcd	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Zydus Lifesciences Limited	1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Zydus Pharmaceuticals (USA) Inc.	d4a34138-a01b-418f-8e0f-e81f6e1cfd89	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	664da979-a480-4482-a5a5-0ec98d4c0037	2024-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	NuCare Pharmaceuticals, Inc.	40bd3a0c-368f-64e9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	86102abe-0b72-4352-95ce-db88d2e14002	2024-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PROCHLORPERAZINE MALEATE generic name: PROCHLORPERAZINE MALEATE
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Chartwell RX, LLC	91adec24-fac8-4a56-b2c3-ae4bbc1160bf	2024-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Prochlorperazine Maleate generic name: PROCHLORPERAZINE MALEATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-9643	Prochlorperazine Maleate	Prochlorperazine Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-9652	Prochlorperazine Maleate	Prochlorperazine Maleate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42708-048	Prochlorperazine Maleate	Prochlorperazine Maleate	QPharma Inc	ANDA	Current
42708-048	Prochlorperazine Maleate	Prochlorperazine Maleate	QPharma Inc	ANDA	Current
50090-0109	Prochlorperazine Maleate	Prochlorperazine Maleate	A-S Medication Solutions	ANDA	Current
61919-532	Prochlorperazine Maleate	Prochlorperazine Maleate	DIRECT RX	ANDA	Current
63187-877	Prochlorperazine Maleate	Prochlorperazine Maleate	Proficient Rx LP	ANDA	Current
63187-877	Prochlorperazine Maleate	Prochlorperazine Maleate	Proficient Rx LP	ANDA	Current
63629-1335	Prochlorperazine Maleate	Prochlorperazine Maleate	Bryant Ranch Prepack	ANDA	Current
67296-0570	Prochlorperazine Maleate	Prochlorperazine Maleate	RedPharm Drug, Inc.	ANDA	Current
67296-0577	Prochlorperazine Maleate	Prochlorperazine Maleate	RedPharm Drug, Inc.	ANDA	Current
67296-0577	Prochlorperazine Maleate	Prochlorperazine Maleate	RedPharm Drug, Inc.	ANDA	Current
68071-1881	Prochlorperazine Maleate	Prochlorperazine Maleate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9819	Prochlorperazine Maleate	Prochlorperazine Maleate	Preferred Pharmaceuticals, Inc	ANDA	Current
71335-0633	Prochlorperazine Maleate	Prochlorperazine Maleate	Bryant Ranch Prepack	ANDA	Current