NDC 66116-434 Paroxetine

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:
66116-434
Proprietary Name:
Paroxetine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Medvantx, Inc.
Labeler Code:
66116
Start Marketing Date: [9]
10-03-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
9;3;7115
Score:
2

Product Packages

NDC Code 66116-434-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 66116-434?

The NDC code 66116-434 is assigned by the FDA to the product Paroxetine which is product labeled by Medvantx, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 66116-434-30 30 tablet, film coated 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 Paroxetine?

The use of MAOIs intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting paroxetine tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION). Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).Paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets.

Which are Paroxetine UNII Codes?

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

  • PAROXETINE HYDROCHLORIDE ANHYDROUS (UNII: 3I3T11UD2S)
  • PAROXETINE (UNII: 41VRH5220H) (Active Moiety)

Which are Paroxetine 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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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".