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  4. NDC Product Code: 76438-002 Pimozide

NDC 76438-002 Pimozide

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 76438-002?
  4. Pimozide Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
76438-002
Proprietary Name:
Pimozide
Non-Proprietary Name: [1]
Pimozide
Substance Name: [2]
Pimozide
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Anthem Biosciences Pvt Ltd
Labeler Code:
76438
Marketing Category: [8]
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date: [9]
09-06-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
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Product Details

What is NDC 76438-002?

The NDC code 76438-002 is assigned by the FDA to the UNFINISHED product Pimozide which is a bulk ingredient product labeled by Anthem Biosciences Pvt Ltd. The generic name of Pimozide is pimozide. The product's dosage form is powder. The product is distributed in a single package with assigned NDC code 76438-002-01 10000 g in 1 drum . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Pimozide?

This medication is used to reduce uncontrolled movements (motor tics) or outbursts of words/sounds (vocal tics) caused by Tourette syndrome. Pimozide is a medication that works by decreasing the activity of a natural substance (dopamine) in the brain. Pimozide should not be used for mild symptoms. It should only be used if symptoms cause severe problems in everyday life and other medicines or treatments have not been effective.

What are Pimozide Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PIMOZIDE 1 g/g - A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to HALOPERIDOL for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403)

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Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.