prochlorperazine edisylate

Product NDC: 70121-1580
11-digit product format: 701211580
Labeler code: 70121
Product ID: 70121-1580_b2472628-fee8-47a2-b345-6e95911a99b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: prochlorperazine edisylate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA214192
Marketing category: ANDA
Marketing start: 2022-12-12
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
A214192-001	PROCHLORPERAZINE EDISYLATE	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION			2022-11-28

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.

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	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2022-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-11-28	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214192-001	PROCHLORPERAZINE EDISYLATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2022-11-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214192-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214192-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214192-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214192-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214192-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214192-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214192-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214192-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214192-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214192-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214192-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214192-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214192-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214192-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214192-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214192-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214192-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214192-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214192-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214192-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214192-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214192-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214192-001	AP	1	`3bdfa0b2c4d7…`

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
e913d678-7a5d-4e74-9e9c-1b9a3affd265	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
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
70121-1580-1	prochlorperazine edisylate	2 mL in 1 VIAL	INJECTION	2	7
70121-1580-5	prochlorperazine edisylate	25 in 1 CARTON	INJECTION	25	7
70121-1580-7	prochlorperazine edisylate	10 in 1 CARTON	INJECTION	10	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70121-1580-1	ML - Milliliter	70121-1580	0852700b-ebe6-454b-8290-b0d4025c9a77	1	2023-04-07
70121-1580-5	ML - Milliliter	70121-1580	760e94ca-a796-4335-a380-6eeaf579562c	1	2023-04-07
70121-1580-7	ML - Milliliter	70121-1580	49f1a709-7bf0-414d-82fb-5fb77886d78a	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70121-1580	PROCHLORPERAZINE EDISYLATE INJECTION [AMNEAL PHARMACEUTICALS LLC]	5	Current NDC, Legacy NDC, 3 package rows	20231228_e913d678-7a5d-4e74-9e9c-1b9a3affd265.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
prochlorperazine edisylate	PROCHLORPERAZINE EDISYLATE	Amneal Pharmaceuticals LLC	e913d678-7a5d-4e74-9e9c-1b9a3affd265	2024-11-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214192 application number: ANDA214192 ndc (product): 70121-1580

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	e913d678-7a5d-4e74-9e9c-1b9a3affd265	7
2102949	prochlorperazine 5 MG/ML Injectable Solution	SCD	e913d678-7a5d-4e74-9e9c-1b9a3affd265	7
2102949	prochlorperazine (as edisylate) 5 MG/ML Injectable Solution	SY	e913d678-7a5d-4e74-9e9c-1b9a3affd265	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70121-1580-1	70121158001	2 mL in 1 VIAL	2 ml					Historical
70121-1580-5	70121158005	25 VIAL in 1 CARTON (70121-1580-5) / 2 mL in 1 VIAL (70121-1580-1)	25 vial	2022-12-12	0000-00-00	No	No	Current
70121-1580-7	70121158007	10 VIAL in 1 CARTON (70121-1580-7) / 2 mL in 1 VIAL (70121-1580-1)	10 vial	2022-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Prochlorperazine Edisylate Injection, USP 10 mg/2 mL (5 mg/mL) Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2024-11-16	HUMAN PRESCRIPTION DRUG LABEL	7