PROCHLORPERAZINE EDISYLATE

Product NDC: 25021-790
Requested package NDC: 25021-790-02
11-digit product format: 250210790
Labeler code: 25021
Product ID: 25021-790_e4de2fb5-4489-416c-8c92-25529704ae26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROCHLORPERAZINE EDISYLATE
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA214107
Marketing category: ANDA
Marketing start: 2021-11-15
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 43.

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
A214107-001	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP		2021-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214107-001	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
2026-09-14 22:38:34	2026-08	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214107-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2021-09-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214107-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214107-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214107-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214107-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214107-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214107-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214107-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214107-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214107-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214107-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214107-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214107-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214107-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214107-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214107-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214107-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214107-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214107-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214107-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214107-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214107-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214107-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214107-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214107-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214107-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214107-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214107-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214107-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214107-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214107-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214107-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214107-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214107-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214107-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214107-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

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

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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	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	SPL version
25021-790-02	PROCHLORPERAZINE EDISYLATE	10 in 1 CARTON	INJECTION	10	2
25021-790-02	PROCHLORPERAZINE EDISYLATE	2 mL in 1 VIAL	INJECTION	2	2
25021-790-03	PROCHLORPERAZINE EDISYLATE	2 mL in 1 VIAL	INJECTION	2	2
25021-790-03	PROCHLORPERAZINE EDISYLATE	25 in 1 CARTON	INJECTION	25	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-790-02	ML - Milliliter	25021-790	328af7d9-f9bb-4132-b43d-87eb2117f8a5	1	2022-02-07
25021-790-03	ML - Milliliter	25021-790	79da60da-e8c4-4d34-a749-f7a0c10c2cf5	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-790	PROCHLORPERAZINE EDISYLATE INJECTION [SAGENT PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 4 package rows	20221201_fed5ed29-7091-4b3c-bf67-64f32cd189bb.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	FOSUN PHARMA USA INC	f793cdb3-9fd8-79e1-e053-6394a90ae08b	2024-12-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214107 application number: ANDA214107
Prochlorperazine Edisylate	PROCHLORPERAZINE EDISYLATE	Gland Pharma Limited	a0fd3d58-7470-4d0f-9e6c-84e92c02a97f	2024-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214107 application number: ANDA214107
PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	Sagent Pharmaceuticals	fed5ed29-7091-4b3c-bf67-64f32cd189bb	2022-11-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214107 application number: ANDA214107 ndc (package): 25021-790-02 ndc (product): 25021-790 ndc11 (package): 25021079002

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	fed5ed29-7091-4b3c-bf67-64f32cd189bb	2
2102949	prochlorperazine 5 MG/ML Injectable Solution	SCD	fed5ed29-7091-4b3c-bf67-64f32cd189bb	2
2102949	prochlorperazine (as edisylate) 5 MG/ML Injectable Solution	SY	fed5ed29-7091-4b3c-bf67-64f32cd189bb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-790-02	25021079002	10 VIAL in 1 CARTON (25021-790-02) / 2 mL in 1 VIAL	10 vial	2021-11-15	0000-00-00	No	No	Current