NDC 70518-0458 Perphenazine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
70518-0458
Proprietary Name:
Perphenazine
Product Type: [3]
Labeler Name: [5]
Labeler Code:
70518
FDA Application Number: [6]
ANDA040226
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
04-24-2017
End Marketing Date: [10]
04-04-2022
Listing Expiration Date: [11]
04-04-2022
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
GRAY (C48324)
Shape:
ROUND (C48348)
Size(s):
9 MM
Imprint(s):
4942;V
Score:
1

Code Structure Chart

Product Details

What is NDC 70518-0458?

The NDC code 70518-0458 is assigned by the FDA to the product Perphenazine which is product labeled by Remedyrepack Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 70518-0458-0 30 tablet, film coated in 1 blister pack , 70518-0458-1 100 pouch in 1 box / 1 tablet, film coated in 1 pouch (70518-0458-2). 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 Perphenazine?

This medication is used to treat certain mental/mood disorders (e.g., schizophrenia, manic phase of bipolar disorder, schizoaffective disorder). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggressive behavior and the desire to hurt yourself/others. It may also help to decrease hallucinations (e.g., hearing/seeing things that are not there). Perphenazine is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances (e.g., dopamine) in the brain.

Which are Perphenazine UNII Codes?

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

Which are Perphenazine Inactive Ingredients 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:

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Patient Education

Perphenazine


Perphenazine is 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). Perphenazine is also used to control severe nausea and vomiting in adults. Perphenazine is in a class of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.
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Product Footnotes

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

[6] 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.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".