prochlorperazine maleate

Product NDC
59651-774
11-digit product format
596510774
Labeler code
59651
Product ID
59651-774_7ec4df20-9ea5-4a68-a43f-5ded4eaed235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA218734
Marketing category
ANDA
Marketing start
2025-09-08
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
59651-774-01prochlorperazine maleate100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-774-01EA - Each59651-774cf683e1d-2164-4e61-adf2-19e1276d246b12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN7ec4df20-9ea5-4a68-a43f-5ded4eaed2351
312635prochlorperazine maleate 5 MG Oral TabletPSN7ec4df20-9ea5-4a68-a43f-5ded4eaed2351
198365prochlorperazine 10 MG Oral TabletSCD7ec4df20-9ea5-4a68-a43f-5ded4eaed2351
312635prochlorperazine 5 MG Oral TabletSCD7ec4df20-9ea5-4a68-a43f-5ded4eaed2351
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY7ec4df20-9ea5-4a68-a43f-5ded4eaed2351
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY7ec4df20-9ea5-4a68-a43f-5ded4eaed2351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-774-0159651077401100 TABLET, FILM COATED in 1 BOTTLE (59651-774-01) 2025-09-08NoNoCurrent