Prochlorperazine

Product NDC: 50090-0636
Requested package NDC: 50090-0636-2
11-digit product format: 500900636
Labeler code: 50090
Product ID: 50090-0636_7af2b0e0-3f08-4830-b620-d74a00669371
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: A-S Medication Solutions
Application: ANDA040058
Marketing category: ANDA
Marketing start: 1993-11-30
Marketing end: 0000-00-00
Substance: PROCHLORPERAZINE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-0636	50090-0636-2	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A040058-001	PROCHLORPERAZINE	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040058-001	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 · 42 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	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040058-001	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB	RS	1993-11-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A040058-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040058-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040058-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040058-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040058-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040058-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040058-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040058-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040058-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040058-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040058-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040058-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040058-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040058-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040058-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040058-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040058-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040058-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040058-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040058-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040058-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040058-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040058-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040058-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040058-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040058-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040058-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040058-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040058-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040058-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040058-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040058-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040058-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040058-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040058-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040058-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040058-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040058-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040058-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040058-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0636-0	2023-01-30	C162847	48780-1	f386c649-d890-0266-e053-dadaa90a7c1a	PROCHLORPERAZINE SUPPOSITORIES, USP
50090-0636-2	2023-01-30	C162847	48780-1	f386c649-d890-0266-e053-dadaa90a7c1a	PROCHLORPERAZINE SUPPOSITORIES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0636-0	Prochlorperazine	12 in 1 CARTON	SUPPOSITORY	12	15
50090-0636-0	Prochlorperazine	1 in 1 BLISTER PACK	SUPPOSITORY	1	15
50090-0636-2	Prochlorperazine	1 in 1 BLISTER PACK	SUPPOSITORY	1	15
50090-0636-2	Prochlorperazine	3 in 1 CARTON	SUPPOSITORY	3	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0636	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [A-S MEDICATION SOLUTIONS]	15	Legacy NDC, 4 package rows	20210616_85e774cd-4e55-4c2b-872d-0d7602862ede.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	PROCHLORPERAZINE	Cosette Pharmaceuticals, Inc.	9595346e-76e5-e155-341b-ffaaafb885ab	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040058 application number: ANDA040058

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YHP6YLT61T	PROCHLORPERAZINE	58-38-8	PROCHLORPERAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198159	prochlorperazine 25 MG Rectal Suppository	PSN	85e774cd-4e55-4c2b-872d-0d7602862ede	15
198159	prochlorperazine 25 MG Rectal Suppository	SCD	85e774cd-4e55-4c2b-872d-0d7602862ede	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0636-2	50090063602	3 BLISTER PACK in 1 CARTON (50090-0636-2) > 1 SUPPOSITORY in 1 BLISTER PACK	3 blister pack	2014-11-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCHLORPERAZINE SUPPOSITORIES, USP	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	15