NDC 54868-6087 Fexofenadine Hydrochloride And Pseudoephedrine 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:
54868-6087
Proprietary Name:
Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride
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]
01-07-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE AND TAN)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
93;T13
Score:
1

Product Packages

NDC Code 54868-6087-0

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

NDC Code 54868-6087-1

Package Description: 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Code 54868-6087-2

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

Product Details

What is NDC 54868-6087?

The NDC code 54868-6087 is assigned by the FDA to the product Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 54868-6087-0 60 tablet, film coated, extended release in 1 bottle , 54868-6087-1 10 tablet, film coated, extended release in 1 bottle , 54868-6087-2 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 Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride?

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).

Which are Fexofenadine Hydrochloride And Pseudoephedrine Hydrochloride UNII Codes?

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

Which are Fexofenadine Hydrochloride And Pseudoephedrine 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 Fexofenadine Hydrochloride And Pseudoephedrine 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:
  • RxCUI: 997406 - fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet
  • RxCUI: 997406 - 12 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet
  • RxCUI: 997406 - fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral Tablet

* 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".