Application 040185

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	TABLET;ORAL	EQ 10MG BASE	No	No
002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	TABLET;ORAL	EQ 5MG 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
A040185-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL			1996-10-28
A040185-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL			1996-10-28

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL		1996-10-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL		1996-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	1996-10-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	1996-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	1996-10-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	1996-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	1996-10-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	1996-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040185-001	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	1996-10-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040185-002	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	1996-10-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040185-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040185-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040185-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040185-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040185-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040185-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040185-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040185-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040185-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040185-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040185-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040185-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040185-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040185-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040185-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040185-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040185-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040185-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040185-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040185-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040185-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040185-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040185-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040185-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040185-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040185-002	AB	1	`ea99ee380514…`
2022-09-29 23:25 UTC	2022-09	A040185-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A040185-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040185-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040185-002	AB	1	`cb3db0bc1861…`

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 3 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	Proficient Rx LP	565e4b1b-04be-47b4-99b0-903fc2ed47af	2023-10-01	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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5105	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5105	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5110	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5110	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-2519	Prochlorperazine Maleate	prochlorperazine maleate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-2520	Prochlorperazine Maleate	prochlorperazine maleate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
35356-672	Prochlorperazine Maleate	prochlorperazine maleate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43063-160	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-353	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-353	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-353	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-607	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-0110	Prochlorperazine Maleate	prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50090-0110	Prochlorperazine Maleate	prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50090-0111	Prochlorperazine Maleate	prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50090-1854	Prochlorperazine Maleate	prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
50090-1854	Prochlorperazine Maleate	prochlorperazine maleate	A-S Medication Solutions	ANDA	Current
51079-541	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Institutional Inc.	ANDA	Current
51079-541	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Institutional Inc.	ANDA	Current
51079-542	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Institutional Inc.	ANDA	Current
51079-542	Prochlorperazine Maleate	prochlorperazine maleate	Mylan Institutional Inc.	ANDA	Current
55154-5094	Prochlorperazine Maleate	prochlorperazine maleate	Cardinal Health	ANDA	Current
55154-5094	Prochlorperazine Maleate	prochlorperazine maleate	Cardinal Health	ANDA	Current
55289-224	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-224	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-224	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-224	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-568	Prochlorperazine Maleate	prochlorperazine maleate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-653	Prochlorperazine Maleate	Prochlorperazine Maleate	Direct_Rx	ANDA	Current
67296-0027	Prochlorperazine Maleate	prochlorperazine maleate	RedPharm Drug, Inc.	ANDA	Current
67296-1405	Prochlorperazine Maleate	Prochlorperazine Maleate	RedPharm Drug, Inc.	ANDA	Current
67296-1405	Prochlorperazine Maleate	Prochlorperazine Maleate	RedPharm Drug, Inc.	ANDA	Current
70518-0768	Prochlorperazine Maleate	prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
70518-0768	Prochlorperazine Maleate	prochlorperazine maleate	REMEDYREPACK INC.	ANDA	Current
71335-0543	Prochlorperazine Maleate	prochlorperazine maleate	Bryant Ranch Prepack	ANDA	Current
71335-0543	Prochlorperazine Maleate	prochlorperazine maleate	Bryant Ranch Prepack	ANDA	Current