PROCHLORPERAZINE MALEATE

Product NDC
72789-517
11-digit product format
727890517
Labeler code
72789
Product ID
72789-517_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
5 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 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
72789-517-01PROCHLORPERAZINE MALEATE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
72789-517-90PROCHLORPERAZINE MALEATE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-517-01EA - Each72789-5170761340b-4d22-4ffc-be9e-d7aa1d76c81e12025-09-12
72789-517-90EA - Each72789-517c1fc5ffe-cab7-4214-b758-c655435a4a1a12025-09-12

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
72789-517-0172789051701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-517-01) 2025-07-28NoNoHistorical
72789-517-907278905179090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-517-90) 2025-07-28NoNoHistorical