NDC 50090-3748 Ziprasidone Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
50090-3748
Proprietary Name:
Ziprasidone Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
A-s Medication Solutions
Labeler Code:
50090
Start Marketing Date: [9]
05-14-2012
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327 - PURPLE BODY)
WHITE (C48325 - WHITE CAP)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
APO;ZIP;20
Score:
1

Product Packages

NDC Code 50090-3748-0

Package Description: 40 CAPSULE in 1 BOTTLE

Product Details

What is NDC 50090-3748?

The NDC code 50090-3748 is assigned by the FDA to the product Ziprasidone Hydrochloride which is product labeled by A-s Medication Solutions. The product's dosage form is . The product is distributed in a single package with assigned NDC code 50090-3748-0 40 capsule in 1 bottle . 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 Ziprasidone Hydrochloride?

Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia.  When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’ s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)].  Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]SchizophreniaZiprasidone hydrochloride capsules are indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1)].Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)Ziprasidone hydrochloride capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [see Clinical Studies (14.2)].Ziprasidone hydrochloride capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies (14.2)].

Which are Ziprasidone Hydrochloride UNII Codes?

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

Which are Ziprasidone Hydrochloride 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:

What is the NDC to RxNorm Crosswalk for Ziprasidone Hydrochloride?

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

Ziprasidone


Ziprasidone 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). It is also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Ziprasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances 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.

[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".