Prochlorperazine Edisylate

Product NDC: 65145-119
11-digit product format: 651450119
Labeler code: 65145
Product ID: 65145-119_5b239257-b476-4705-b408-bcf1d0003305
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine Edisylate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Caplin Steriles Limited
Application: ANDA214379
Marketing category: ANDA
Marketing start: 2026-04-08
Substance: PROCHLORPERAZINE EDISYLATE
Active strength: 5 mg/mL
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214379-001	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2021-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214379-001	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214379-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-04-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214379-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214379-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214379-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214379-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214379-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214379-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214379-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214379-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214379-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214379-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214379-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214379-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214379-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214379-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214379-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214379-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214379-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214379-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214379-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214379-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214379-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214379-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214379-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214379-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214379-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214379-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214379-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214379-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214379-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214379-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214379-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214379-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214379-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214379-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROCHLORPERAZINE EDISYLATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PG20W5VQZS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2102949	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
29f0e68d-4653-472d-bd86-e87a8e2cb529	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
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
65145-119-01	Prochlorperazine Edisylate	2 mL in 1 VIAL	INJECTION	2		6
65145-119-10	Prochlorperazine Edisylate	10 in 1 CARTON	INJECTION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65145-119-01	ML - Milliliter	65145-119	6cef0eb8-5b2d-4e88-b705-bbb0188b281f	1	2024-10-04
65145-119-10	ML - Milliliter	65145-119	ab041121-cdbf-4f0f-9132-df7be27a51e7	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65145-119	PROCHLORPERAZINE EDISYLATE INJECTION [CAPLIN STERILES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20241012_29f0e68d-4653-472d-bd86-e87a8e2cb529.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Caplin Steriles Limited	29f0e68d-4653-472d-bd86-e87a8e2cb529	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214379 application number: ANDA214379 ndc (product): 65145-119
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Baxter Healthcare Corporation	11cb37c7-01b4-4223-b2ea-a3695639b80b	2021-04-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214379 application number: ANDA214379

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PG20W5VQZS	PROCHLORPERAZINE EDISYLATE	1257-78-9	PROCHLORPERAZINE EDISYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2102949	prochlorperazine 5 MG/ML Injectable Solution	PSN	29f0e68d-4653-472d-bd86-e87a8e2cb529	6
2102949	prochlorperazine 5 MG/ML Injectable Solution	SCD	29f0e68d-4653-472d-bd86-e87a8e2cb529	6
2102949	prochlorperazine (as edisylate) 5 MG/ML Injectable Solution	SY	29f0e68d-4653-472d-bd86-e87a8e2cb529	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65145-119-01	65145011901	2 mL in 1 VIAL	2 ml					Historical
65145-119-10	65145011910	10 VIAL in 1 CARTON (65145-119-10) / 2 mL in 1 VIAL (65145-119-01)	10 vial	2026-04-08		No	No	Current
65145-119-25	65145011925	25 VIAL in 1 CARTON (65145-119-25) > 2 mL in 1 VIAL (65145-119-01)	25 vial	2021-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prochlorperazine Edisylate Injectio, USP Rx Only	Caplin Steriles Limited	2026-04-08	Human Prescription Drug Label	6