PROCHLORPERAZINE MALEATE

Product NDC
63629-1841
11-digit product format
636291841
Labeler code
63629
Product ID
63629-1841_6b9a2a78-c721-46ff-a1a5-0c557d161b8a
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
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
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1841DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-1DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-2DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-3DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-4DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-5DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-6DDiscontinued by firm2026-08-07
excluded packagepackage63629-184163629-1841-7DDiscontinued 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 2 · 104 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 packagepackage63629-1841-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1841-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1841-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1841-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1841-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1841-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1841-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1841-5f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1841-52ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1841-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1841-5cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1841-5cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1841-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1841-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1841-7ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1841-2ed331223b511…672a5bd82f5f…

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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1841-1EA - Each63629-1841079ad808-4a4d-4d0a-9b8d-c3a13ce1cde312012-07-24
63629-1841-2EA - Each63629-18413e3b8cd1-18a6-4282-92b5-8545309544e112015-02-02
63629-1841-3EA - Each63629-1841c28e870c-a636-4155-86d0-3d7f1f367f9412015-02-02
63629-1841-4EA - Each63629-1841322a445d-04eb-450a-8de8-8bb50a52be4512015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCHLORPERAZINE MALEATEACTIVE INGREDIENTI1T8O1JTL6PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROCHLORPERAZINE MALEATE TABLET [BRYANT RANCH PREPACK]1002

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1841-16362918410120 TABLET in 1 BOTTLE (63629-1841-1) 20 tablet2011-03-070000-00-00NoNoCurrent
63629-1841-26362918410210 TABLET in 1 BOTTLE (63629-1841-2) 10 tablet2011-03-070000-00-00NoNoCurrent
63629-1841-36362918410330 TABLET in 1 BOTTLE (63629-1841-3) 30 tablet2011-03-070000-00-00NoNoCurrent
63629-1841-46362918410460 TABLET in 1 BOTTLE (63629-1841-4) 60 tablet2011-03-070000-00-00NoNoCurrent
63629-1841-56362918410590 TABLET in 1 BOTTLE (63629-1841-5) 90 tablet2005-08-240000-00-00NoNoCurrent
63629-1841-663629184106120 TABLET in 1 BOTTLE (63629-1841-6) 120 tablet2005-08-240000-00-00NoNoCurrent
63629-1841-7636291841076 TABLET in 1 BOTTLE (63629-1841-7) 6 tablet2005-08-240000-00-00NoNoCurrent