FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
72789-518
11-digit product format
727890518
Labeler code
72789
Product ID
72789-518_4603a67f-05af-5931-e063-6394a90afcf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE MALEATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA218912
Marketing category
ANDA
Marketing start
2025-07-28
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
72789-518-01PROCHLORPERAZINE MALEATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
72789-518-15PROCHLORPERAZINE MALEATE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED155
72789-518-90PROCHLORPERAZINE MALEATE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-518-01EA - Each72789-5180a7787df-1fd9-47d6-a676-20fca290baa212025-09-12
72789-518-15EA - Each72789-518a9260dd1-29b7-45dc-861a-bd105c07f2a712026-01-08
72789-518-90EA - Each72789-518722cf929-f2d5-4853-80b3-c9a78bdff7ab12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN3b022837-0fcc-d38a-e063-6394a90a0f7f5
312635prochlorperazine maleate 5 MG Oral TabletPSN3b022837-0fcc-d38a-e063-6394a90a0f7f5
198365prochlorperazine 10 MG Oral TabletSCD3b022837-0fcc-d38a-e063-6394a90a0f7f5
312635prochlorperazine 5 MG Oral TabletSCD3b022837-0fcc-d38a-e063-6394a90a0f7f5
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY3b022837-0fcc-d38a-e063-6394a90a0f7f5
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY3b022837-0fcc-d38a-e063-6394a90a0f7f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-518-0172789051801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-01) 2025-07-28NoNoHistorical
72789-518-157278905181515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-15) 2025-12-15NoNoHistorical
72789-518-907278905189090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-518-90) 2025-07-28NoNoHistorical