Prochlorperazine Maleate

Product NDC
70518-4319
11-digit product format
705184319
Labeler code
70518
Product ID
70518-4319_402e606f-d63c-9455-e063-6394a90a5994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA218515
Marketing category
ANDA
Marketing start
2025-03-25
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

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
70518-4319-0Prochlorperazine Maleate10 in 1 BOTTLE, PLASTICTABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4319PROCHLORPERAZINE MALEATE (PROCHLORPERAZINE MALEATE) TABLET [REMEDYREPACK INC.]1Current NDC, 1 package rows20250327_851dddc0-26da-48eb-b039-cd85384ce864.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN851dddc0-26da-48eb-b039-cd85384ce8642
198365prochlorperazine 10 MG Oral TabletSCD851dddc0-26da-48eb-b039-cd85384ce8642
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY851dddc0-26da-48eb-b039-cd85384ce8642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4319-07051843190010 TABLET in 1 BOTTLE, PLASTIC (70518-4319-0) 10 tablet2025-03-25NoNoHistorical