Prochlorperazine Maleate Tablet
NDC Package 67296-2342-4

11-digit billing NDC: 67296234204
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Prochlorperazine Maleate tablets is for control of severe nausea and vomiting.For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. This formulation utilizes a tablet delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2342 and is authorized under FDA application ANDA216202.

Identification & Billing

NDC Package Code
67296-2342-4
Package Description
15 TABLET in 1 BOTTLE
Product Code
67296-2342
11-Digit Billing Format
67296234204

Clinical Specifications

Proprietary Name
Prochlorperazine Maleate
Non-Proprietary Name
Prochlorperazine Maleate
Substance Name
Prochlorperazine Maleate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROCHLORPERAZINE MALEATE 10 mg/1
Pharmacologic Class
Usage Information
For control of severe nausea and vomiting.For the treatment of schizophrenia.Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA216202
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-07-2023
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-2342-4 identifies a specific commercial package of 15 tablet in 1 bottle of Prochlorperazine Maleate, a human prescription drug labeled by Redpharm Drug. This tablet is formulated for oral use and contains prochlorperazine maleate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Redpharm Drug on September 07, 2023. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296234204. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
67296-2342-4
11-Digit CMS (5-4-2)
67296-2342-04

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.