PROCHLORPERAZINE MALEATE

Product NDC
61919-327
11-digit product format
619190327
Labeler code
61919
Product ID
61919-327_86e85717-1e94-e6e9-e053-2a91aa0afdb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040268
Marketing category
ANDA
Marketing start
2017-02-22
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE MALEATE
Active strength
5 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct61919-327DDiscontinued by firm2026-08-07
excluded packagepackage61919-32761919-327-30DDiscontinued by firm2026-08-07

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 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 packagepackage61919-327-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-327-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-327-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-327-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-327-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-327-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-327-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-327-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-327-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-327-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-327-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-327-30557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040268-001PROCOMPPROCHLORPERAZINE MALEATEEQ 5MG BASETABLET / ORALAB1998-02-27
A040268-002PROCOMPPROCHLORPERAZINE MALEATEEQ 10MG BASETABLET / ORALABRS1998-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040268-001AB
A040268-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040268-002PROCOMPEQ 10MG BASETABLET / ORALAB1998-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27782e0a99824c…
2021-12-28 21:50 UTC2021-12A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040268-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040268-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040268-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040268-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040268-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040268-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040268-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040268-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040268-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040268-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040268-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040268-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040268-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040268-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040268-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040268-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040268-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040268-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040268-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040268-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040268-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040268-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040268-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040268-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040268-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040268-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040268-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040268-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040268-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040268-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040268-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040268-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040268-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040268-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040268-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040268-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040268-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040268-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040268-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040268-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-327-30EA - Each61919-327d04567dd-9a7b-412f-bd7c-6c87c83da31a12017-11-06

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATESportpharm LLC3d28dab2-0264-482e-b99d-f56a9314b8a52026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEREMEDYREPACK INC.5fbf5fc6-a2d9-4e5d-8485-e6e949ca497d2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEPD-Rx Pharmaceuticals, Inc.fc77a504-4642-47c1-b2e3-c5db11e5816d2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBryant Ranch Prepack7e3aa80a-3a5f-4937-b5aa-4ce2aa6ece1b2026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEA-S Medication Solutions8b58b63c-0a75-406b-bb29-acf0a40353bd2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENorthwind Health Company, LLCc524a28e-1e08-4aa6-a9f0-0a3280a3c2132026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENorthwind Health Company, LLCf2f12ccc-6e51-0a67-e053-2995a90a22bc2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEQPharma, Inc.dc692e77-5240-4aa6-8fe9-9ffcbb2672612025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEJubilant Cadista Pharmaceuticals Inc.b05bc20e-cd19-ab40-1ad0-84a115d6d69e2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATECardinal Health 107, LLC45f56f93-50a7-4cd3-bce2-f97a805566512025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEAvPAK86ac7223-b840-bc0c-e053-2991aa0a32f22025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
Prochlorperazine MaleatePROCHLORPERAZINE MALEATEDirect_Rx02069e43-5245-20dc-e063-6294a90a9dcd2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEBryant Ranch Prepack664da979-a480-4482-a5a5-0ec98d4c00372024-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATENuCare Pharmaceuticals, Inc.40bd3a0c-368f-64e9-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
PROCHLORPERAZINE MALEATEPROCHLORPERAZINE MALEATEProficient Rx LP565e4b1b-04be-47b4-99b0-903fc2ed47af2023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268
ProchlorperazinePROCHLORPERAZINEPharmPak, Inc.383744db-ba57-478a-8041-2ecc26d3e1ec2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040268
application number: ANDA040268