NDC 16590-514 Paxil CR

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:
16590-514
Proprietary Name:
Paxil CR
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Start Marketing Date: [9]
04-09-2002
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
7 MM
Imprint(s):
PAXIL;CR;12;5
Score:
1

Product Packages

NDC Code 16590-514-30

Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 16590-514-60

Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

NDC Code 16590-514-90

Package Description: 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 16590-514?

The NDC code 16590-514 is assigned by the FDA to the product Paxil CR which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 16590-514-30 30 tablet, film coated, extended release in 1 bottle, plastic , 16590-514-60 60 tablet, film coated, extended release in 1 bottle, plastic , 16590-514-90 90 tablet, film coated, extended release in 1 bottle, plastic . 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 Paxil CR?

Paroxetine is used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Paroxetine is known as a selective serotonin reuptake inhibitor (SSRI). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand washing, counting, and checking) that interfere with daily living.

Which are Paxil CR UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Paxil CR?

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:
  • RxCUI: 1738803 - PARoxetine HCl 12.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1738803 - 24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet
  • RxCUI: 1738803 - paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 1738804 - PAXIL CR 12.5 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1738804 - 24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet [Paxil]

* Please review the disclaimer below.

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".