Prochlorperazine Maleate

Product NDC: 82868-044
Requested package NDC: 82868-044-30
11-digit product format: 828680044
Labeler code: 82868
Product ID: 82868-044_47a70b0b-9e78-e333-e063-6394a90a6bd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA216495
Marketing category: ANDA
Marketing start: 2024-02-06
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 1.

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
A216495-001	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB		2022-08-08
A216495-002	PROCHLORPERAZINE MALEATE	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB		2022-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216495-001	AB
A216495-002	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 · 54 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
2026-02-19 14:30 UTC	2026-02	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216495-001	PROCHLORPERAZINE MALEATE	EQ 5MG BASE	TABLET / ORAL	AB	2022-08-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216495-002	PROCHLORPERAZINE MALEATE	EQ 10MG BASE	TABLET / ORAL	AB	2022-08-08	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216495-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216495-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216495-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216495-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216495-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216495-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216495-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216495-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216495-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216495-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216495-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216495-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216495-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216495-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216495-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216495-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216495-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216495-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216495-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216495-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216495-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216495-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216495-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216495-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216495-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216495-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216495-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216495-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216495-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216495-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216495-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216495-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216495-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216495-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216495-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216495-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216495-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216495-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216495-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216495-002	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prochlorperazine Maleate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROCHLORPERAZINE MALEATE	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198365	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
115a4125-07df-9f9b-e063-6394a90a3e49	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
82868-044-30	Prochlorperazine Maleate	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82868-044	PROCHLORPERAZINE MALEATE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20240220_115a4125-07df-9f9b-e063-6394a90a3e49.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Northwind Health Company, LLC	115a4125-07df-9f9b-e063-6394a90a3e49	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216495 application number: ANDA216495 ndc (package): 82868-044-30 ndc (product): 82868-044 ndc11 (package): 82868004430
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	REMEDYREPACK INC.	5c1dd0ea-89e9-4317-a83e-5e15da79ca20	2025-09-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216495 application number: ANDA216495
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Zydus Lifesciences Limited	1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216495 application number: ANDA216495
Prochlorperazine Maleate	PROCHLORPERAZINE MALEATE	Zydus Pharmaceuticals (USA) Inc.	d4a34138-a01b-418f-8e0f-e81f6e1cfd89	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216495 application number: ANDA216495

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	115a4125-07df-9f9b-e063-6394a90a3e49	3
198365	prochlorperazine 10 MG Oral Tablet	SCD	115a4125-07df-9f9b-e063-6394a90a3e49	3
198365	prochlorperazine (as prochlorperazine maleate) 10 MG Oral Tablet	SY	115a4125-07df-9f9b-e063-6394a90a3e49	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82868-044-30	82868004430	30 TABLET in 1 BOTTLE, PLASTIC (82868-044-30)	30 tablet	2024-02-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only	Northwind Health Company, LLC	2026-01-05	HUMAN PRESCRIPTION DRUG LABEL	3