Prochlorperazine Maleate

Product NDC
67296-0027
11-digit product format
672960027
Labeler code
67296
Product ID
67296-0027_3fb514f8-ea98-60ca-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine maleate
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040185
Marketing category
ANDA
Marketing start
2016-05-09
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-0027IInactivated by FDA2026-08-17
excluded packagepackage67296-002767296-0027-2IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-0027-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-0027-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-0027-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-0027-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-0027-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-0027-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-0027-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-0027-2IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-0027-2IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-0027-2IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-0027-2IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-0027-2IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0027-2IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0027-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0027-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-0027-2IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-0027-2IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-0027-2IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67296-0027-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67296-0027-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67296-0027-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-0027-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040185-001PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28
A040185-002PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORAL1996-10-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORAL1996-10-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040185-001PROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALAB1996-10-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040185-002PROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1996-10-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040185-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040185-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040185-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040185-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040185-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040185-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040185-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040185-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040185-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040185-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040185-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040185-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040185-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040185-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040185-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040185-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040185-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040185-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040185-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040185-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040185-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040185-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040185-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040185-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040185-002AB1ea99ee380514…
2022-09-29 23:25 UTC2022-09A040185-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A040185-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040185-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040185-002AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0027-22020-01-31C16284748780-19d75b9d0-8de8-f424-e053-dadaa90a57ce3fb514f8-ea97-60ca-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0027-2Prochlorperazine Maleate10 in 1 BOTTLETABLET1012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0027PROCHLORPERAZINE MALEATE TABLET [REDPHARM DRUG, INC.]12Legacy NDC, 1 package rows20161026_3fb514f8-ea97-60ca-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN3fb514f8-ea97-60ca-e054-00144ff8d46c12
198365prochlorperazine 10 MG Oral TabletSCD3fb514f8-ea97-60ca-e054-00144ff8d46c12
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY3fb514f8-ea97-60ca-e054-00144ff8d46c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67296-0027-26729600270210 in 1 BOTTLEHistorical