Drugplain

Prochlorperazine Maleate 10 mg/1

Prochlorperazine Maleate · TABLET · ANI Pharmaceuticals, Inc.

2 Recalls on Record
Plain English

Prochlorperazine maleate is an antipsychotic and antiemetic medication used to treat nausea, vomiting, and certain mental health conditions. This prescription tablet is taken by mouth and comes in a 10 mg strength.

Key Facts

Brand Name
Prochlorperazine Maleate
Generic Name
Prochlorperazine Maleate
NDC Code (Product)
70954-689
Manufacturer
ANI Pharmaceuticals, Inc.
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA216202
Marketing Start
08/01/2022

Recall History

2 Recalls on Record
Class II03/13/2025

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations

OngoingVoluntary: Firm initiated
Class III12/27/2022

Jubilant Cadista Pharmaceuticals, Inc.

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue1,259 reports
nausea1,256 reports
diarrhoea940 reports
death685 reports
vomiting626 reports
asthenia535 reports
decreased appetite502 reports
off label use437 reports
constipation416 reports
pain395 reports

Frequently Asked Questions

What is Prochlorperazine Maleate used for?

Prochlorperazine maleate is an antipsychotic and antiemetic medication used to treat nausea, vomiting, and certain mental health conditions. This prescription tablet is taken by mouth and comes in a 10 mg strength.

Is Prochlorperazine Maleate a controlled substance?

Prochlorperazine Maleate is not classified as a controlled substance by the DEA.

What is the generic name for Prochlorperazine Maleate?

The generic name for Prochlorperazine Maleate is Prochlorperazine Maleate. There are 7 other brand versions of Prochlorperazine Maleate.

What is the NDC code for Prochlorperazine Maleate 10 mg/1?

The NDC (National Drug Code) for Prochlorperazine Maleate 10 mg/1 is 70954-689, listed by ANI Pharmaceuticals, Inc..