Prochlorperazine Maleate
NDC 10544-511

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 10544-511?
  5. Prochlorperazine Maleate Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Prochlorperazine Maleate is a ANDA-approved product labeled by Blenheim Pharmacal, Inc.. This medication is used to treat severe nausea and vomiting from certain causes (for example, after surgery or cancer treatment). It is supplied as a green product. This product entry covers the primary NDC 10544-511 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
10544-511
Proprietary Name:
Prochlorperazine Maleate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Blenheim Pharmacal, Inc.
Labeler Code:
10544
Product Label ID:
0ff320ac-60f3-4b75-e054-00144ff88e88
FDA Application Number: [6]
ANDA040268
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-01-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GREEN (C48329 - CHARTREUSE)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
TL113
Score:
2

Code Structure Chart

Product Details

What is NDC 10544-511?

The NDC code 10544-511 is assigned by the FDA to the product Prochlorperazine Maleate. This pharmaceutical product is labeled by Blenheim Pharmacal, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 10544-511-06. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Prochlorperazine


Prochlorperazine suppositories and tablets are used to control severe nausea and vomiting. Prochlorperazine tablets are also used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Prochlorperazine tablets are also used on a short-term basis to treat anxiety that could not be controlled by other medications. Prochlorperazine should not be used to treat any condition in children who are younger than 2 years old or who weigh less than 20 pounds (about 9 kilograms). Prochlorperazine is in a class of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".