Prochlorperazine Maleate

Product NDC
71335-0543
11-digit product format
713350543
Labeler code
71335
Product ID
71335-0543_da39155b-9fe4-4539-8522-7f12f339b6e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040185
Marketing category
ANDA
Marketing start
1996-11-18
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0543DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-7DDiscontinued by firm2026-08-17
excluded packagepackage71335-054371335-0543-8DDiscontinued by firm2026-08-17

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 2 · 108 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0543-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0543-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0543-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0543-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0543-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0543-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0543-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0543-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0543-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0543-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0543-8302b2466d912…e7b80fea0513…

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…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0543-17133505430110 TABLET, FILM COATED in 1 BOTTLE (71335-0543-1) 2017-09-190000-00-00NoNoCurrent
71335-0543-27133505430230 TABLET, FILM COATED in 1 BOTTLE (71335-0543-2) 2017-09-190000-00-00NoNoCurrent
71335-0543-37133505430320 TABLET, FILM COATED in 1 BOTTLE (71335-0543-3) 2017-09-190000-00-00NoNoCurrent
71335-0543-47133505430460 TABLET, FILM COATED in 1 BOTTLE (71335-0543-4) 2017-09-190000-00-00NoNoCurrent
71335-0543-5713350543054 TABLET, FILM COATED in 1 BOTTLE (71335-0543-5) 2017-09-190000-00-00NoNoCurrent
71335-0543-6713350543065 TABLET, FILM COATED in 1 BOTTLE (71335-0543-6) 2017-09-190000-00-00NoNoCurrent
71335-0543-771335054307100 TABLET, FILM COATED in 1 BOTTLE (71335-0543-7) 2017-09-190000-00-00NoNoCurrent
71335-0543-8713350543086 TABLET, FILM COATED in 1 BOTTLE (71335-0543-8) 2017-09-190000-00-00NoNoCurrent