PROCHLORPERAZINE MALEATE

Product NDC
70518-4498
11-digit product format
705184498
Labeler code
70518
Product ID
70518-4498_41096a22-a36c-964f-e063-6394a90afb9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217478
Marketing category
ANDA
Marketing start
2025-10-11
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
I1T8O1JTL6PROCHLORPERAZINE MALEATE84-02-6PROCHLORPERAZINE MALEATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4498-07051844980020 TABLET in 1 BOTTLE, PLASTIC (70518-4498-0) 20 tablet2025-10-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prochlorperazine Maleate Tablets, USP Rx OnlyREMEDYREPACK INC.2025-10-13HUMAN PRESCRIPTION DRUG LABEL1