PROCHLORPERAZINE MALEATE

Product NDC: 59746-113
11-digit product format: 597460113
Labeler code: 59746
Product ID: 59746-113_15ccaf96-5c2f-45cb-992c-99f5458da55b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA040268
Marketing category: ANDA
Marketing start: 1998-03-01
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
A040268-001	PROCOMP	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27
A040268-002	PROCOMP	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040268-001	AB
A040268-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB		1998-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040268-001	PROCOMP	EQ 5MG BASE	TABLET / ORAL	AB		1998-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040268-002	PROCOMP	EQ 10MG BASE	TABLET / ORAL	AB	RS	1998-02-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A040268-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040268-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040268-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040268-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040268-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040268-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040268-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040268-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040268-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040268-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040268-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040268-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040268-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040268-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040268-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040268-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040268-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040268-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040268-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040268-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040268-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040268-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040268-002	AB	1	`bb7c543d1eb4…`

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
b05bc20e-cd19-ab40-1ad0-84a115d6d69e	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
59746-113-06	PROCHLORPERAZINE MALEATE	100 in 1 BOTTLE	TABLET	100		9
59746-113-10	PROCHLORPERAZINE MALEATE	1000 in 1 BOTTLE	TABLET	1000		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59746-113-06	EA - Each	59746-113	a4abdc86-b9cb-41b7-bb1a-a5287acd9b1b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROCHLORPERAZINE MALEATE	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
PROCHLORPERAZINE	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]	1002
Prochlorperazine Maleate	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Prochlorperazine Maleate	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Prochlorperazine	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Prochlorperazine	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Fd&c Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Fd&c Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]	3
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]	3
PROCHLORPERAZINE MALEATE	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
Prochlorperazine Maleate	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
PROCHLORPERAZINE MALEATE	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET [NORTHWIND PHARMACEUTICALS]	1
PROCHLORPERAZINE MALEATE	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
PROCHLORPERAZINE MALEATE	ACTIVE INGREDIENT	I1T8O1JTL6	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
PROCHLORPERAZINE	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Prochlorperazine	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
PROCHLORPERAZINE	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
PROCHLORPERAZINE	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET [NORTHWIND PHARMACEUTICALS]	1
PROCHLORPERAZINE	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Fd&c Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
Polyethylene Glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE TABLET [LIBERTY PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [BLENHEIM PHARMACAL, INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-113	PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241127_b05bc20e-cd19-ab40-1ad0-84a115d6d69e.zip

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Sportpharm LLC	3d28dab2-0264-482e-b99d-f56a9314b8a5	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	PD-Rx Pharmaceuticals, Inc.	fc77a504-4642-47c1-b2e3-c5db11e5816d	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	A-S Medication Solutions	8b58b63c-0a75-406b-bb29-acf0a40353bd	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	f2f12ccc-6e51-0a67-e053-2995a90a22bc	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	QPharma, Inc.	dc692e77-5240-4aa6-8fe9-9ffcbb267261	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Jubilant Cadista Pharmaceuticals Inc.	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268 ndc (product): 59746-113
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Cardinal Health 107, LLC	45f56f93-50a7-4cd3-bce2-f97a80556651	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	AvPAK	86ac7223-b840-bc0c-e053-2991aa0a32f2	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Direct_Rx	02069e43-5245-20dc-e063-6294a90a9dcd	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Bryant Ranch Prepack	664da979-a480-4482-a5a5-0ec98d4c0037	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	NuCare Pharmaceuticals, Inc.	40bd3a0c-368f-64e9-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	Proficient Rx LP	565e4b1b-04be-47b4-99b0-903fc2ed47af	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268
Prochlorperazine	PROCHLORPERAZINE	PharmPak, Inc.	383744db-ba57-478a-8041-2ecc26d3e1ec	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040268 application number: ANDA040268

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	8b58b63c-0a75-406b-bb29-acf0a40353bd	18
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	8b58b63c-0a75-406b-bb29-acf0a40353bd	18
198365	prochlorperazine 10 MG Oral Tablet	SCD	8b58b63c-0a75-406b-bb29-acf0a40353bd	18
312635	prochlorperazine 5 MG Oral Tablet	SCD	8b58b63c-0a75-406b-bb29-acf0a40353bd	18
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	8b58b63c-0a75-406b-bb29-acf0a40353bd	18
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	8b58b63c-0a75-406b-bb29-acf0a40353bd	18
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	9
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	9
198365	prochlorperazine 10 MG Oral Tablet	SCD	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	9
312635	prochlorperazine 5 MG Oral Tablet	SCD	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	9
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	9
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	b05bc20e-cd19-ab40-1ad0-84a115d6d69e	9
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	565e4b1b-04be-47b4-99b0-903fc2ed47af	6
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	565e4b1b-04be-47b4-99b0-903fc2ed47af	6
198365	prochlorperazine 10 MG Oral Tablet	SCD	565e4b1b-04be-47b4-99b0-903fc2ed47af	6
312635	prochlorperazine 5 MG Oral Tablet	SCD	565e4b1b-04be-47b4-99b0-903fc2ed47af	6
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	565e4b1b-04be-47b4-99b0-903fc2ed47af	6
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	565e4b1b-04be-47b4-99b0-903fc2ed47af	6
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	40bd3a0c-368f-64e9-e054-00144ff88e88	5
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	4175d760-a84d-0b7f-e054-00144ff88e88	5
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	5
312635	prochlorperazine 5 MG Oral Tablet	SCD	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	5
312635	prochlorperazine 5 MG Oral Tablet	SCD	4175d760-a84d-0b7f-e054-00144ff88e88	5
312635	prochlorperazine 5 MG Oral Tablet	SCD	40bd3a0c-368f-64e9-e054-00144ff88e88	5
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	4175d760-a84d-0b7f-e054-00144ff88e88	5
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	40bd3a0c-368f-64e9-e054-00144ff88e88	5
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	c524a28e-1e08-4aa6-a9f0-0a3280a3c213	5
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	86ac7223-b840-bc0c-e053-2991aa0a32f2	4
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	86ac7223-b840-bc0c-e053-2991aa0a32f2	4
198365	prochlorperazine 10 MG Oral Tablet	SCD	86ac7223-b840-bc0c-e053-2991aa0a32f2	4
312635	prochlorperazine 5 MG Oral Tablet	SCD	86ac7223-b840-bc0c-e053-2991aa0a32f2	4
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	86ac7223-b840-bc0c-e053-2991aa0a32f2	4
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	86ac7223-b840-bc0c-e053-2991aa0a32f2	4
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	383744db-ba57-478a-8041-2ecc26d3e1ec	2
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	a4ea65db-8118-564c-e053-2995a90adcfa	2
312635	prochlorperazine 5 MG Oral Tablet	SCD	383744db-ba57-478a-8041-2ecc26d3e1ec	2
312635	prochlorperazine 5 MG Oral Tablet	SCD	a4ea65db-8118-564c-e053-2995a90adcfa	2
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	383744db-ba57-478a-8041-2ecc26d3e1ec	2
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	a4ea65db-8118-564c-e053-2995a90adcfa	2
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	0ff320ac-60f3-4b75-e054-00144ff88e88	1
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	a49905cc-dd53-43a2-8113-d8ada3f8cae9	1
198365	prochlorperazine maleate 10 MG Oral Tablet	PSN	717a36cb-4353-4eda-9f0a-ca3fb34522cf	1
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	717a36cb-4353-4eda-9f0a-ca3fb34522cf	1
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	0ff320ac-60f3-4b75-e054-00144ff88e88	1
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	a49905cc-dd53-43a2-8113-d8ada3f8cae9	1
312635	prochlorperazine maleate 5 MG Oral Tablet	PSN	a9111024-b249-4974-b174-d0b98a492ac0	1
198365	prochlorperazine 10 MG Oral Tablet	SCD	0ff320ac-60f3-4b75-e054-00144ff88e88	1
198365	prochlorperazine 10 MG Oral Tablet	SCD	a49905cc-dd53-43a2-8113-d8ada3f8cae9	1
198365	prochlorperazine 10 MG Oral Tablet	SCD	717a36cb-4353-4eda-9f0a-ca3fb34522cf	1
312635	prochlorperazine 5 MG Oral Tablet	SCD	a49905cc-dd53-43a2-8113-d8ada3f8cae9	1
312635	prochlorperazine 5 MG Oral Tablet	SCD	a9111024-b249-4974-b174-d0b98a492ac0	1
312635	prochlorperazine 5 MG Oral Tablet	SCD	0ff320ac-60f3-4b75-e054-00144ff88e88	1
312635	prochlorperazine 5 MG Oral Tablet	SCD	717a36cb-4353-4eda-9f0a-ca3fb34522cf	1
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	a49905cc-dd53-43a2-8113-d8ada3f8cae9	1
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	0ff320ac-60f3-4b75-e054-00144ff88e88	1
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	717a36cb-4353-4eda-9f0a-ca3fb34522cf	1
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	a9111024-b249-4974-b174-d0b98a492ac0	1
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	a49905cc-dd53-43a2-8113-d8ada3f8cae9	1
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	717a36cb-4353-4eda-9f0a-ca3fb34522cf	1
312635	prochlorperazine 5 MG (as prochlorperazine maleate) Oral Tablet	SY	0ff320ac-60f3-4b75-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-113-06	59746011306	100 TABLET in 1 BOTTLE (59746-113-06)	100 tablet	1998-03-01	0000-00-00	No	No	Current
59746-113-10	59746011310	1000 TABLET in 1 BOTTLE (59746-113-10)	1000 tablet	1998-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Sportpharm LLC	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	1
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	A-S Medication Solutions	2026-02-20	Human Prescription Drug Label	18
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited \| Aavis Pharmaceuticals Inc.	2025-12-05	Human Prescription Drug Label	9
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	AvPAK	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	4
PROCHLORPERAZINE MALEATE TABLETS USP Rx Only	NuCare Pharmaceuticals, Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	5
PROCHLORPERAZINE MALEATE TABLETS USP Rx Only	Proficient Rx LP	2023-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
Prochlorperazine Rx Only	PharmPak, Inc.	2022-10-09	HUMAN PRESCRIPTION DRUG LABEL	2
PROCHLORPERAZINE MALEATE - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	5
Prochlorperazine Maleate Tablets, USP Rx Only	AvKARE	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	A-S Medication Solutions	2021-08-10	HUMAN PRESCRIPTION DRUG LABEL	10
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	NuCare Pharmaceuticals,Inc.	2021-02-18	HUMAN PRESCRIPTION DRUG LABEL	2
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	1006
PROCHLORPERAZINE MALEATE TABLETS USP Rx Only	Blenheim Pharmacal, Inc.	2015-02-25	HUMAN PRESCRIPTION DRUG LABEL	1
PROCHLORPERAZINE MALEATE TABLETS USP Rx Only	Aidarex Pharmaceuticals LLC	2014-01-28	HUMAN PRESCRIPTION DRUG LABEL	1
PROCHLORPERAZINE MALEATE TABLETS USP Rx Only	Liberty Pharmaceuticals, Inc.	2013-09-11	HUMAN PRESCRIPTION DRUG LABEL	1
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	1