Thiothixene
NDC 53808-1129

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53808-1129?
  5. Thiothixene 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.

Thiothixene is a ANDA-approved product labeled by Doh Central Pharmacy. Thiothixene is used to treat certain mental/mood disorders (such as schizophrenia). It is supplied as a brown product. This product entry covers the primary NDC 53808-1129 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53808-1129
Proprietary Name:
Thiothixene
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Doh Central Pharmacy
Labeler Code:
53808
Product Label ID:
d9909bb6-3ccd-487c-8228-f955135ed38f
FDA Application Number: [6]
ANDA071093
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-28-2017
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Product Characteristics

Color(s):
BROWN (C48332 - CARAMEL OPAQUE)
YELLOW (C48330 - YELLOW OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
12 MM
Imprint(s):
MYLAN;2002
Score:
1

Code Structure Chart

Product Details

What is NDC 53808-1129?

The NDC code 53808-1129 is assigned by the FDA to the product Thiothixene. This pharmaceutical product is labeled by Doh Central Pharmacy 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: 53808-1129-1. 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?

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

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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

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Patient Education

Thiothixene


Thiothixene 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). Thiothixene is in a group of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.
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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".