Prochlorperazine Maleate Tablet, Film Coated
NDC Package 69452-310-32

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Prochlorperazine Maleate tablets is a medication used to treat severe nausea and vomiting from certain causes (for example, after surgery or cancer treatment). This formulation utilizes a tablet, film coated delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-310 and is authorized under FDA application ANDA217478.

Identification & Billing

NDC Package Code
69452-310-32
Package Description
1000 TABLET, FILM COATED in 1 BOTTLE
Product Code
69452-310
11-Digit Billing Format
69452031032
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prochlorperazine Maleate
Non-Proprietary Name
Prochlorperazine Maleate
Substance Name
Prochlorperazine Maleate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROCHLORPERAZINE MALEATE 10 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat severe nausea and vomiting from certain causes (for example, after surgery or cancer treatment). Prochlorperazine belongs to a class of drugs known as phenothiazines. This medication is not recommended for use in children younger than 2 years or in children going through surgery.

Regulatory & Marketing

Labeler Name
Bionpharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217478
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-13-2023
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69452-310). Click a package code to view its specific billing and regulatory data.

69452-310-20
100 TABLET, FILM COATED in 1 BOTTLE

* 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 69452-310-32 identifies a specific commercial package of 1000 tablet, film coated in 1 bottle of Prochlorperazine Maleate, a human prescription drug labeled by Bionpharma Inc.. This tablet, film coated 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 Bionpharma Inc. on September 13, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat severe nausea and vomiting from certain causes (for example, after surgery or cancer treatment). Prochlorperazine belongs to a class of drugs known as phenothiazines. This medication is not recommended for use in children younger than 2 years or in children going through surgery.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452031032. 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 (5-3-2)
69452-310-32
11-Digit CMS (5-4-2)
69452-0310-32

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