FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
68462-889
11-digit product format
684620889
Labeler code
68462
Product ID
68462-889_87ee1668-fd00-4e54-8c72-14ca91b94e0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE MALEATE
Dosage form
TABLET
Route
ORAL
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA216595
Marketing category
ANDA
Marketing start
2023-03-17
Substance
PROCHLORPERAZINE MALEATE
Active strength
5 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROCHLORPERAZINE MALEATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE5 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
68462-889-01PROCHLORPERAZINE MALEATE100 in 1 BOTTLETABLET1004
68462-889-10PROCHLORPERAZINE MALEATE1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-889-01EA - Each68462-889a3d04925-b92d-46ec-a23e-42dcdfda3d9612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-889PROCHLORPERAZINE MALEATE TABLET [GLENMARK PHARMACEUTICALS INC., USA]2Current NDC, 2 package rows20241016_9c806152-70d0-43eb-b183-b51b12b82b31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN9c806152-70d0-43eb-b183-b51b12b82b314
312635prochlorperazine maleate 5 MG Oral TabletPSN9c806152-70d0-43eb-b183-b51b12b82b314
198365prochlorperazine 10 MG Oral TabletSCD9c806152-70d0-43eb-b183-b51b12b82b314
312635prochlorperazine 5 MG Oral TabletSCD9c806152-70d0-43eb-b183-b51b12b82b314
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY9c806152-70d0-43eb-b183-b51b12b82b314
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY9c806152-70d0-43eb-b183-b51b12b82b314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-889-0168462088901100 TABLET in 1 BOTTLE (68462-889-01) 100 tablet2023-03-17NoNoHistorical
68462-889-10684620889101000 TABLET in 1 BOTTLE (68462-889-10) 1000 tablet2023-03-17NoNoHistorical