prochlorperazine maleate

Product NDC
59651-773
11-digit product format
596510773
Labeler code
59651
Product ID
59651-773_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
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 formatDescriptionMarketing startSampleExclude flagStatus
59651-773-0159651077301100 TABLET, FILM COATED in 1 BOTTLE (59651-773-01) 2025-09-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prochlorperazine Maleate Tablets, USP Rx onlyAurobindo Pharma Limited2025-09-11Human Prescription Drug Label1