PROCHLORPERAZINE MALEATE

Product NDC
71335-0952
11-digit product format
713350952
Labeler code
71335
Product ID
71335-0952_a679eeac-1846-44fc-b6e2-446fb486786b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040268
Marketing category
ANDA
Marketing start
1998-03-01
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
PROCHLORPERAZINE MALEATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I1T8O1JTL6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198365Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
664da979-a480-4482-a5a5-0ec98d4c0037Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0952-1PROCHLORPERAZINE MALEATE10 in 1 BOTTLETABLET105
71335-0952-2PROCHLORPERAZINE MALEATE30 in 1 BOTTLETABLET305
71335-0952-3PROCHLORPERAZINE MALEATE20 in 1 BOTTLETABLET205
71335-0952-4PROCHLORPERAZINE MALEATE60 in 1 BOTTLETABLET605
71335-0952-5PROCHLORPERAZINE MALEATE4 in 1 BOTTLETABLET45
71335-0952-6PROCHLORPERAZINE MALEATE5 in 1 BOTTLETABLET55
71335-0952-7PROCHLORPERAZINE MALEATE100 in 1 BOTTLETABLET1005
71335-0952-8PROCHLORPERAZINE MALEATE6 in 1 BOTTLETABLET65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0952PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20240901_664da979-a480-4482-a5a5-0ec98d4c0037.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
ndc (product): 71335-0952
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 TabletPSN664da979-a480-4482-a5a5-0ec98d4c00375
198365prochlorperazine 10 MG Oral TabletSCD664da979-a480-4482-a5a5-0ec98d4c00375
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY664da979-a480-4482-a5a5-0ec98d4c00375

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0952-17133509520110 TABLET in 1 BOTTLE (71335-0952-1) 10 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-27133509520230 TABLET in 1 BOTTLE (71335-0952-2) 30 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-37133509520320 TABLET in 1 BOTTLE (71335-0952-3) 20 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-47133509520460 TABLET in 1 BOTTLE (71335-0952-4) 60 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-5713350952054 TABLET in 1 BOTTLE (71335-0952-5) 4 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-6713350952065 TABLET in 1 BOTTLE (71335-0952-6) 5 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-771335095207100 TABLET in 1 BOTTLE (71335-0952-7) 100 tablet2006-03-140000-00-00NoNoCurrent
71335-0952-8713350952086 TABLET in 1 BOTTLE (71335-0952-8) 6 tablet2006-03-140000-00-00NoNoCurrent