NDC 54868-5347 Paxilcr 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:
54868-5347
Proprietary Name:
Paxilcr CR
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
07-06-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
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 54868-5347-0

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

Product Details

What is NDC 54868-5347?

The NDC code 54868-5347 is assigned by the FDA to the product Paxilcr CR which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-5347-0 30 tablet, film coated, extended release 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 Paxilcr CR?

The use of MAOIs intended to treat depression with, or within 14 days of treatment with, PAXIL CR is contraindicated (see WARNINGS). Do not start PAXIL CR in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS).Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS).Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).PAXIL CR is contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL CR.

Which are Paxilcr CR UNII Codes?

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

Which are Paxilcr CR 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 Paxilcr 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".