Compro

Product NDC: 63629-8444
11-digit product format: 636298444
Labeler code: 63629
Product ID: 63629-8444_a8e747fd-847c-49a6-a1df-103e6241f55b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROCHLORPERAZINE
Dosage form: SUPPOSITORY
Route: RECTAL
Labeler: Bryant Ranch Prepack
Application: ANDA040246
Marketing category: ANDA
Marketing start: 2000-09-01
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-8444		D	Discontinued by firm		2026-08-17
excluded package	package	63629-8444	63629-8444-1	D	Discontinued by firm		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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-8444-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-8444-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-8444-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-8444-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-8444-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-8444-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-8444-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-8444-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-8444-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-8444-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-8444-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-8444-1	I	Inactivated by FDA	`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
A040246-001	COMPRO	PROCHLORPERAZINE	25MG	SUPPOSITORY / RECTAL	AB		2000-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040246-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040246-001	COMPRO	25MG	SUPPOSITORY / RECTAL	AB	2000-06-28	`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	A040246-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040246-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040246-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040246-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040246-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040246-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040246-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040246-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040246-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040246-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040246-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040246-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040246-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040246-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040246-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040246-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040246-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040246-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040246-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040246-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040246-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040246-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040246-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040246-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040246-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040246-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040246-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040246-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040246-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040246-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040246-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040246-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040246-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040246-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040246-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040246-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040246-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040246-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040246-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040246-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-8444-1	2024-05-10	C162847	48780-1	1030e365-35c3-111a-e063-dadaa90a10e2	PRESCRIBING INFORMATION COMPRO ® PROCHLORPERAZINE SUPPOSITORIES USP, 25 mg Rx only
63629-8444-1	2024-01-30	C162847	48780-1	1030e365-35c3-111a-e063-dadaa90a10e2	PRESCRIBING INFORMATION COMPRO ® PROCHLORPERAZINE SUPPOSITORIES USP, 25 mg Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8444-1	EA - Each	63629-8444	43b27715-ffa9-49f2-b0c9-2e75e894c532	1	2021-06-02

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
Compro	PROCHLORPERAZINE	PD-Rx Pharmaceuticals, Inc.	b23b67eb-78b7-48eb-84ff-c95d3ce8683c	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040246 application number: ANDA040246
Compro	PROCHLORPERAZINE	Padagis US LLC	ea381bc5-0957-4c91-826a-0ff680cebacc	2024-11-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040246 application number: ANDA040246

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8444-1	63629844401	12 PACKET in 1 CARTON (63629-8444-1) > 1 SUPPOSITORY in 1 PACKET	12 packet	2021-04-29	0000-00-00	No	No	Current