Prochlorperazine

Product NDC: 0713-0135
11-digit product format: 007130135
Labeler code: 0713
Product ID: 0713-0135_462a6c34-db6d-8d31-e063-6294a90ae196
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Prochlorperazine
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: ANDA040058
Marketing category: ANDA
Marketing start: 1993-11-30
Substance: PROCHLORPERAZINE
Active strength: 25 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Prochlorperazine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROCHLORPERAZINE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YHP6YLT61T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198159	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
9595346e-76e5-e155-341b-ffaaafb885ab	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
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
0713-0135-10	Prochlorperazine	1 in 1 BLISTER PACK	SUPPOSITORY	1	10
0713-0135-10	Prochlorperazine	1000 in 1 CARTON	SUPPOSITORY	1000	10
0713-0135-12	Prochlorperazine	1 in 1 BLISTER PACK	SUPPOSITORY	1	10
0713-0135-12	Prochlorperazine	12 in 1 CARTON	SUPPOSITORY	12	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0135-10	EA - Each	0713-0135	e00681ee-89cf-4c16-b364-e165eb0bc1e7	1	2013-02-13
0713-0135-12	EA - Each	0713-0135	4c4b09ed-acdd-40b2-8794-9ec83a02b3d1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Prochlorperazine	ACTIVE INGREDIENT	YHP6YLT61T	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]	4
Prochlorperazine	ACTIVE MOIETY	YHP6YLT61T	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]	4
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]	4
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]	4
Hydrogenated Coconut Oil	INACTIVE INGREDIENT	JY81OXM1OM	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]	4
Palm Kernel Oil	INACTIVE INGREDIENT	B0S90M0233	PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0713-0135	PROCHLORPERAZINE SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20231130_9595346e-76e5-e155-341b-ffaaafb885ab.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 ndc (product): 0713-0135

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
198159	prochlorperazine 25 MG Rectal Suppository	PSN	9595346e-76e5-e155-341b-ffaaafb885ab	10
198159	prochlorperazine 25 MG Rectal Suppository	SCD	9595346e-76e5-e155-341b-ffaaafb885ab	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0713-0135-10	00713013510	1000 BLISTER PACK in 1 CARTON (0713-0135-10) / 1 SUPPOSITORY in 1 BLISTER PACK	1000 blister pack	1993-11-30	0000-00-00	No	No	Current
0713-0135-12	00713013512	12 BLISTER PACK in 1 CARTON (0713-0135-12) / 1 SUPPOSITORY in 1 BLISTER PACK	12 blister pack	1993-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROCHLORPERAZINE SUPPOSITORIES, USP	Cosette Pharmaceuticals, Inc. \| Cosette Pharmaceuticals NC Laboratories, LLC	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	10
PROCHLORPERAZINE SUPPOSITORIES, USP	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	15
PROCHLORPERAZINE SUPPOSITORIES, USP	NuCare Pharmaceuticals,Inc. \| NuCare Pharmceuticals,Inc.	2018-01-19	HUMAN PRESCRIPTION DRUG LABEL	1
PROCHLORPERAZINE SUPPOSITORIES, USP	NuCare Pharmaceuticals, Inc.	2017-05-22	HUMAN PRESCRIPTION DRUG LABEL	1