PROCHLORPERAZINE

Product NDC
54348-114
Requested package NDC
54348-114-02
11-digit product format
543480114
Labeler code
54348
Product ID
54348-114_ea92a656-4fd4-df01-e053-2a95a90a9de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA040268
Marketing category
ANDA
Marketing start
2019-07-12
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54348-11454348-114-02IInactivated 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54348-11454348-114-02IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54348-11454348-114-02IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040268-001PROCOMPEQ 5MG BASETABLET / ORALAB1998-02-27caaa826d4ba7…
2026-08-18 06:07:402026-07A040268-002PROCOMPEQ 10MG BASETABLET / ORALABRS1998-02-27caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040268-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040268-002AB1caaa826d4ba7…
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…

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
54348-114-022025-07-29C16284748780-13b156c62-2a47-fb37-e063-e6dba90a4e07PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only
54348-114-042025-07-29C16284748780-13b156c62-2a47-fb37-e063-e6dba90a4e07PROCHLORPERAZINE MALEATE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54348-114-02PROCHLORPERAZINE2 in 1 BOTTLETABLET22
54348-114-02PROCHLORPERAZINE1 in 1 BOXTABLET12
54348-114-04PROCHLORPERAZINE4 in 1 BOTTLETABLET42
54348-114-04PROCHLORPERAZINE1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-114PROCHLORPERAZINE TABLET [PHARMPAK, INC.]2Legacy NDC, 4 package rows20221011_888f253f-1db1-45bc-8fc7-15f97ff0ba18.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN888f253f-1db1-45bc-8fc7-15f97ff0ba182
198365prochlorperazine 10 MG Oral TabletSCD888f253f-1db1-45bc-8fc7-15f97ff0ba182
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY888f253f-1db1-45bc-8fc7-15f97ff0ba182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-114-02543480114021 BOTTLE in 1 BOX (54348-114-02) > 2 TABLET in 1 BOTTLE1 bottle2019-07-120000-00-00NoNoCurrent