PROCHLORPERAZINE MALEATE

Product NDC
63187-251
11-digit product format
631870251
Labeler code
63187
Product ID
63187-251_ba21a8c5-5ab9-4c89-921c-347a068240bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

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 Identifiers#

Field, Values table
FieldValues
UniiI1T8O1JTL6
Rxcui198365, 312635

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
63187-251-15PROCHLORPERAZINE MALEATE15 in 1 BOTTLETABLET156
63187-251-30PROCHLORPERAZINE MALEATE30 in 1 BOTTLETABLET306
63187-251-60PROCHLORPERAZINE MALEATE60 in 1 BOTTLETABLET606
63187-251-90PROCHLORPERAZINE MALEATE90 in 1 BOTTLETABLET906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Prochlorperazine MaleateACTIVE INGREDIENTI1T8O1JTL6PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
ProchlorperazineACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Aluminum OxideINACTIVE INGREDIENTLMI26O6933PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
D&c Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Fd&c Blue No. 2INACTIVE INGREDIENTL06K8R7DQKPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
HypromellosesINACTIVE INGREDIENT3NXW29V3WOPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Starch, CornINACTIVE INGREDIENTO8232NY3SJPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPPROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-251PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20231030_565e4b1b-04be-47b4-99b0-903fc2ed47af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN565e4b1b-04be-47b4-99b0-903fc2ed47af6
312635prochlorperazine maleate 5 MG Oral TabletPSN565e4b1b-04be-47b4-99b0-903fc2ed47af6
198365prochlorperazine 10 MG Oral TabletSCD565e4b1b-04be-47b4-99b0-903fc2ed47af6
312635prochlorperazine 5 MG Oral TabletSCD565e4b1b-04be-47b4-99b0-903fc2ed47af6
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY565e4b1b-04be-47b4-99b0-903fc2ed47af6
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY565e4b1b-04be-47b4-99b0-903fc2ed47af6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-251-156318702511515 TABLET in 1 BOTTLE (63187-251-15) 15 tablet2018-12-010000-00-00NoNoCurrent
63187-251-306318702513030 TABLET in 1 BOTTLE (63187-251-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-251-606318702516060 TABLET in 1 BOTTLE (63187-251-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-251-906318702519090 TABLET in 1 BOTTLE (63187-251-90) 90 tablet2018-12-010000-00-00NoNoCurrent